42144 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 

1Finding of Fact 40 and, presumably, 

Respondent’s first exception concern the 2006 

inspection. 

Commission’s public service list were 

not labeled as containing BPI. 

In determining the appropriate action 

in response to the breach, the 

Commission considered mitigating 

factors, including that (1) the breach 

was unintentional and due to a 

technical oversight; (2) the attorney had 

not been found to have breached an 

APO over the past two years; (3) the 

attorney took immediate corrective 

measures upon learning of the 

disclosure by immediately contacting 

the Secretary’s Office and the recipients 

of the brief; and (4) the attorney 

promptly reported the violation to the 

Commission. The Commission 

determined that no aggravating factors 

were present. The Commission issued a 

private warning letter to the attorney. 

By order of the Commission. 

Issued: August 14, 2018. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2018–17848 Filed 8–17–18; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Antitrust Division 

Notice Pursuant to the National 

Cooperative Research and Production 

Act of 1993—National Fire Protection 

Association 

Notice is hereby given that, on July 

31, 2018, pursuant to Section 6(a) of the 

National Cooperative Research and 

Production Act of 1993, 15 U.S.C. 4301 

et seq. (‘‘the Act’’), National Fire 

Protection Association (‘‘NFPA’’) has 

filed written notifications 

simultaneously with the Attorney 

General and the Federal Trade 

Commission disclosing additions or 

changes to its standards development 

activities. The notifications were filed 

for the purpose of extending the Act’s 

provisions limiting the recovery of 

antitrust plaintiffs to actual damages 

under specified circumstances. 

Specifically, NFPA has provided an 

updated and current list of its standards 

development activities, related technical 

committee and conformity assessment 

activities. Information concerning NFPA 

regulations, technical committees, 

current standards, standards 

development and conformity 

assessment activities are publicly 

available at nfpa.org. 

On September 20, 2004, NFPA filed 

its original notification pursuant to 

Section 6(a) of the Act. The Department 

of Justice published a notice in the 

Federal Register pursuant to Section 

6(b) of the Act on October 21, 2004 (69 

FR 61869). 

The last notification was filed with 

the Department on May 8, 2018. A 

notice was published in the Federal 

Register pursuant to Section 6(b) of the 

Act on May 25, 2018 (83 FR 24348). 

Suzanne Morris 

Chief, Premerger and Division Statistics Unit, 

Antitrust Division. 

[FR Doc. 2018–17899 Filed 8–17–18; 8:45 am] 

BILLING CODE 4410–11–P 

DEPARTMENT OF JUSTICE 

Antitrust Division 

Notice Pursuant to the National 

Cooperative Research and Production 

Act of 1993—National Spectrum 

Consortium 

Notice is hereby given that, on August 

3, 2018, pursuant to Section 6(a) of the 

National Cooperative Research and 

Production Act of 1993, 15 U.S.C. 4301 

et seq. (‘‘the Act’’), National Spectrum 

Consortium (‘‘NSC’’) has filed written 

notifications simultaneously with the 

Attorney General and the Federal Trade 

Commission disclosing changes in its 

membership. The notifications were 

filed for the purpose of extending the 

Act’s provisions limiting the recovery of 

antitrust plaintiffs to actual damages 

under specified circumstances. 

Specifically, Numerati Partners, LLC, 

New York, NY; Avionics Test & 

Analysis Corporation, Niceville, FL; 

George Mason University, Fairfax, VA; 

Science Applications International 

Corporation (SAIC), Reston, VA; 

Southern Research, Birmingham, AL; 

Parsons Government Services Inc., 

Pasadena, CA; Dell Federal Systems, 

L.P., Round Rock, TX; Sentar, Inc., 

Huntsville, AL; SCI Technology, Inc., 

Huntsville, AL; Pacific Star 

Communications, Inc., Portland, OR; 

COMINT Consulting LLC, Golden, CO; 

C6I Services Corp., Chesterfield, NJ; 

Comtech EF Data, Tempe, AZ; Vision 

Engineering Solutions, Inc., Merritt 

Island, FL; Vision Engineering 

Solutions, Inc., Merritt Island, FL; 

Comtech Mobile Datacom Corporation, 

Germantown, MD,; and EFW, Inc., Fort 

Worth, TX, have been added as parties 

to this venture. 

Also, Fibertek, Inc., Herndon, VA; and 

University of Nevada, Reno, VA, have 

withdrawn as parties to this venture. 

No other changes have been made in 

either the membership or planned 

activity of the group research project. 

Membership in this group research 

project remains open, and NSC intends 

to file additional written notifications 

disclosing all changes in membership. 

On May 24, 2014, NSC filed its 

original notification pursuant to Section 

6(a) of the Act. The Department of 

Justice published a notice in the Federal 

Register pursuant to Section 6(b) of the 

Act on November 4, 2014 (72 FR 65424). 

The last notification was filed with 

the Department on May 14, 2018. A 

notice was published in the Federal 

Register pursuant to Section 6(b) of the 

Act on June 19, 2018 (83 FR 28449). 

Suzanne Morris, 

Chief, Premerger and Division Statistics Unit 

Antitrust Division. 

[FR Doc. 2018–17900 Filed 8–17–18; 8:45 am] 

BILLING CODE 4410–11–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Houston Maintenance Clinic; Decision 

and Order 

On September 30, 2016, 

Administrative Law Judge Charles Wm. 

Dorman (hereinafter, ALJ) issued 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

(hereinafter, R.D.). Only Houston 

Maintenance Clinic (hereinafter, 

Respondent) filed exceptions 

(hereinafter, Resp. Exceptions), and its 

filing was timely. Having reviewed the 

entire record, including Resp. 

Exceptions, and modified the ALJ’s 

R.D., I adopt the modified R.D. and find 

that none of Resp. Exceptions has merit. 

Respondent’s First Exception 

Respondent’s first exception states 

that R.D. ‘‘Finding of Fact 40 should be 

amended to include the first sentence in 

. . . [Respondent’s owner’s] letter, GE 

27[,] that states as follows[,] ‘The facility 

has kept a systematic ongoing accurate 

daily dispensing record as required by 

title 21 C.F.R. 1304.03.’ ’’ 1 Resp. 

Exceptions, at 1. The support 

Respondent provided for this exception 

is that, ‘‘The daily dosing records . . . 

are required and these were kept 

without disruption.’’ Id. 

First, R.D. Finding of Fact 30, citing 

GE–27, already states that, ‘‘Around the 

time of the [2006] inspection, . . . 

[Respondent] kept ongoing, systematic 

daily dispensing records’’ [footnote 

omitted]. Thus, much of the content of 

the sentence that Respondent’s first 

exception proposes is already found in 

Finding of Fact 30. Only the assertions 

that Respondent ‘‘has kept . . . 


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2There is evidence in the record that, ‘‘up until 

the time of the 2006 inspection,’’ Respondent ‘‘kept 

meticulous daily dispensing records.’’ R.D., at 39. 

3Finding of Fact 87 concerns the 2014 inspection. 

4 It does cite to page 513 of the hearing transcript, 

but it does not provide a pinpoint citation to what 

it considers to be the relevant material on that page. 

5Although not specifically addressed on page 

513, other portions of the hearing transcript 

indicate that the number for the blank space on 

page 2 of GE–9 in the ‘‘Total Dosage Units 

Received’’ column for ‘‘Methadone’’ received on 

June 24, 2014 is the product of the ‘‘Quantity 

Received (Pkg),’’ (40), and the ‘‘Package Size,’’ 

(4,000). 

accurate’’ daily dispensing records ‘‘as 

required by title 21 C.F.R. 1304.03’’ do 

not appear in Finding of Fact 30. 

Respondent’s first exception does not 

mention Finding of Fact 30 and does not 

explain why it reiterates statements 

found in Finding of Fact 30. 

Second, the Agency’s regulation 

concerning exceptions requires that 

supporting reasons, specific citations to 

the evidence in the record, and 

applicable authorities be included with 

exceptions. The regulation states that, 

‘‘The party shall include a statement of 

supporting reasons for such exceptions, 

together with evidence of record 

(including specific and complete 

citations of the pages of the transcript 

and exhibits) and citations of the 

authorities relied upon.’’ 21 CFR 

1316.66(a) (1979). 

Respondent’s first exception does not 

comply with the Agency’s regulation 

because it does not ‘‘include . . . 

evidence of record (including specific 

and complete citations of the pages of 

the transcript and exhibits).’’ Id. Instead, 

it simply asserts that ‘‘daily dosing 

records . . . were kept without 

disruption.’’ Resp. Exceptions, at 1. It 

does not provide support from evidence 

in the record that Respondent ‘‘has kept 

. . . accurate’’ daily dispensing records 

‘‘as required by title 21 CFR 1304.03.’’ 

Thus, I find that Respondent’s first 

exception does not comply with the 

Agency’s regulation. 21 CFR 1316.66(a) 

(1979). 

Third, the sentence that Respondent 

proposes for addition to the R.D.’s 40th 

Finding of Fact is taken from 

Respondent’s written response (GE–27) 

to the Drug Enforcement Administration 

(hereinafter, DEA or Government) Letter 

of Admonition (GE–26) sent after the 

2006 inspection. The 2006 inspection is 

addressed in subparagraph 2.c. of the 

Order to Show Cause (hereinafter, OSC). 

In pertinent part, the OSC alleges that 

Respondent failed ‘‘to maintain and 

keep accurate records (daily dispensing 

logs) for controlled substances.’’ OSC, at 

2. I am not sustaining this OSC 

allegation due to insufficient evidence 

in the record: ‘‘[T]he Government did 

not enter any evidence specifically 

showing that . . . [Respondent’s] daily 

dispensing records were inadequate at 

the time of the 2006 inspection.’’ 2 R.D., 

at 39. Respondent’s first exception does 

not mention or acknowledge that the 

ALJ recommended against sustaining 

this OSC allegation. Respondent does 

not explain why it proposes an 

exception concerning an allegation that 

the ALJ recommended against 

sustaining. 

Fourth, it does not follow from the 

Government’s lack of proof concerning 

the inadequacy of Respondent’s daily 

dispensing records at the time of the 

2006 inspection that Respondent 

actually kept daily dispensing records 

that were accurate and in compliance 

with Agency regulations. As already 

discussed, Respondent’s first exception 

does not cite to evidence in the record 

that provides a basis for me to find that 

Respondent did keep daily dispending 

records that were accurate and in 

compliance with Agency regulations at 

the time of the 2006 inspection. 

For all of the above reasons, I reject 

Respondent’s first exception. 

Respondent’s Second Exception 

Respondent’s second exception states 

that R.D. ‘‘Finding of Fact 87 should be 

amended to include the fact that the 

investigators’ variance computations 

were incorrect by at least 160,000 mgs 

in the methadone diskettes.’’ 3 Resp. 

Exceptions, at 1. Respondent cites ‘‘Tr. 

513’’ to support this exception. 

First, Respondent’s second exception 

does not comply with the Agency’s 

exception regulation because it does not 

‘‘include a statement of supporting 

reasons.’’ 21 CFR 1316.66(a) (1979). 

Instead, it simply advises that 

‘‘Respondent believes’’ that ‘‘Finding of 

Fact 87 should be amended.’’ 4 Resp. 

Exceptions, at 1. I find that 

Respondent’s second exception also 

does not comply with the applicable 

Agency regulation. 21 CFR 1316.66(a) 

(1979). 

Second, the only support Respondent 

provides for its stated ‘‘belief’’ that the 

87th Finding of Fact ‘‘should be 

amended’’ is its citation to page 513 of 

the hearing transcript. Respondent does 

not, however, specify the particular 

portion of page 513 that is relevant or 

discuss why that material supports its 

second exception. 

Hearing transcript page 513 concerns 

the cross-examination by Respondent’s 

counsel of one of the DEA Diversion 

Investigators (hereinafter, DI) assigned 

to the more recent inspections of 

Respondent. On lines 18 through 24, 

Respondent’s counsel elicits testimony 

from the DI that ‘‘[i]t looks like’’ there 

‘‘may have been an error in . . . [the] 

spreadsheet’’ of ‘‘160,000 milligrams of 

methadone.’’ Tr. 513. This testimony 

appears either to refer to page 2 of GE– 

9, where there is a blank space in the 

‘‘Total Dosage Units Received’’ column 

for ‘‘Methadone’’ received on June 24, 

2014, or to page 1 of GE–9.5 I see no 

reference on page 513 to ‘‘variance 

computations,’’ let alone to variance 

computations being ‘‘incorrect by at 

least 160,000 mgs in the methadone 

diskettes’’ as Respondent’s second 

exception asserts. Thus, the hearing 

transcript page cited in Respondent’s 

second exception is not evidentiary 

support for Respondent’s proposed 

amendment to Finding of Fact 87. 

Third, Respondent’s second exception 

concerns Respondent’s ‘‘belief’’ that 

1,200,050 dosage units, the amount of 

variance in its methadone diskettes 

calculated by the Government during 

the 2014 inspection, is not accurate. 

Respondent does not, however, point to 

any evidence in the record stating the 

correct amount of variance. Even more 

significantly, though, Respondent’s 

second exception clearly acknowledges 

that Respondent’s controlled substance 

inventories included a variance in its 

methadone diskette inventory for the 

2014 inspection time period. 

I am sustaining the OSC allegation 

that the 2014 inspection found 

variances in Respondent’s controlled 

substance inventories of methadone 

diskettes, liquid methadone, 

buprenorphine 2 mg tablets, and 

buprenorphine 8 mg tablets. R.D., at 45. 

As Respondent asserts that the 

Government’s variance computations 

were incorrect ‘‘by at least 160,000 

mgs,’’ it is acknowledging the existence 

of variances. That acknowledgement 

supports my conclusion, concerning the 

2014 inspection, that ‘‘Respondent 

failed to maintain complete and 

accurate records of controlled 

substances received, sold, and 

delivered, and that there was a variance 

in . . . [Respondent’s] controlled 

substance inventory.’’ R.D., at 45. I 

calculated the variance in Respondent’s 

methadone diskette inventory based on 

figures that account for the apparent 

160,000 mg math error. Although the 

recalculated variance is smaller than the 

figure on the first page of GE–9, it does 

not change my findings concerning the 

2014 inspection or my decision to 

revoke. 

For all of the above reasons, I reject 

Respondent’s second exception. 


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6As the Government notes in its Post-Hearing 

Brief, ALJ–27, the code sections cited in the OSC 

are to the current version of the C.F.R., rather than 

the version in effect at the time of the alleged 

violations. The substance of the code remains the 

same. For the sake of clarity and simplicity, the 

current version of the C.F.R. is cited throughout this 

Recommended Decision. 

7 21 C.F.R. 1305.24(a) discusses maintenance of 

ordering records using an electronic central 

processing system. The facts of this case do not 

relate to any alleged violations dealing with 

ordering records maintained on an electronic 

central processing system. Therefore, the 

Government’s allegation that the Respondent’s 

conduct on October 11 and 13, 2011, and October 

14, 2014, violated 21 C.F.R. 1305.24(a) is NOT 

SUSTAINED. 

Order 

Pursuant to 28 CFR 0.100(b) (2018) 

and the authority thus vested in me by 

21 U.S.C. 824(a) (Westlaw through Pub. 

L. No. 115–223) in conjunction with 21 

U.S.C. 823(g)(1) (Westlaw through Pub. 

L. No. 115–223), I order that DEA 

Certificate of Registration No. 

RH0208567 issued to Houston 

Maintenance Clinic be, and it hereby is, 

revoked. I further order that any 

pending application of Houston 

Maintenance Clinic for renewal or 

modification of its registration be, and it 

hereby is, denied. This Order is effective 

September 19, 2018. 

Dated: August 8, 2018. 

Uttam Dhillon, 

Acting Administrator. 

Paul A. Dean, Esq., for the Government 

Andre D’Souza, Esq., for the Respondent 

RECOMMENDED RULINGS, FINDINGS 

OF FACT, CONCLUSIONS OF LAW, 

AND DECISION OF THE 

ADMINISTRATIVE LAW JUDGE 

Charles Wm. Dorman, Administrative 

Law Judge. On September 10, 2015, the 

Drug Enforcement Administration 

(‘‘DEA’’ or ‘‘Government’’) served 

Houston Maintenance Clinic 

(‘‘Respondent’’ or ‘‘HMC’’) with an 

Order to Show Cause (‘‘OSC’’) seeking 

to revoke the Respondent’s DEA 

Certificate of Registration (‘‘COR’’), 

Number RH0208567. Administrative 

Law Judge Exhibits (‘‘ALJ–’’) 1–2. In 

response, the Respondent requested a 

hearing before an Administrative Law 

Judge. ALJ–3. That hearing was held in 

Houston, Texas on June 13 through 16, 

2016. The issue currently before the 

Administrator is whether the DEA 

should revoke the Respondent’s COR, 

pursuant to 21 U.S.C. 824(a), and deny 

any pending applications for renewal or 

modification of its registration, pursuant 

to 21 U.S.C. 823(g)(1). The following 

recommendations are based on my 

consideration of the entire 

administrative record, including all of 

the testimony, admitted exhibits, and 

the oral and written arguments of 

counsel. 

ALLEGATIONS 

1. On April 17, 1997, the DEA 

discovered that the HMC failed to 

record the amount of controlled 

substances received, failed to keep DEA 

222 Order Forms (‘‘222 Forms’’), and 

failed to properly maintain daily 

dispensing records, in violation of 21 

C.F.R. 1304.03, 1304.04, 1304.21, 

1304.22, and 1304.24.1.6 ALJ–1, at 1–2. 

On that date, the DEA found variances 

in the HMC’s controlled substance 

inventory. ALJ–1, at 2. Subsequently, 

the HMC received a letter of admonition 

detailing its violations. ALJ–1, at 2. 

2. On December 6, 1999, the DEA 

discovered that the HMC failed to 

maintain complete and accurate records 

of Schedule II controlled substances 

received and dispensed, in violation of 

21 U.S.C. 827(a)(3) and 21 C.F.R. 

1304.21(a). ALJ–1, at 2. On that date, the 

DEA found variances in the HMC’s 

controlled substance inventory. ALJ–1, 

at 2. Subsequently, the HMC entered a 

Memorandum of Understanding, 

acknowledging its violations. ALJ–1, at 

2. 

3. On September 8 and 11, 2006, the 

DEA discovered that the HMC failed to 

keep and maintain daily dispensing logs 

of controlled substances, in violation of 

21 C.F.R. 1304.21(a). ALJ–1, at 2. On 

that date, the DEA found variances in 

the HMC’s controlled substance 

inventory. ALJ–1, at 2. Subsequently, 

the HMC received a letter of admonition 

detailing its violations. ALJ–1, at 2. 

4. On October 11 and 13, 2011, the 

DEA discovered that the HMC failed to 

provide records in a timely manner, 

failed to maintain complete and 

accurate controlled substance receipt 

records, failed to conduct a biennial 

inventory, failed to preserve 222 Forms 

for two years, improperly allowed an 

unauthorized person to sign 222 Forms, 

failed to execute a power of attorney to 

allow an alternate person to sign 222 

Forms, and failed to completely and 

accurately complete daily dispensing 

logs, in violation of 21 C.F.R. 

1304.04(f)(l)(2), 1304.04, 1304.11(a), 

1305.04, 1305.17(a), 1305.17(c), 

1305.05, and 1305.24(a).7 ALJ–1, at 2. 

The HMC also failed to maintain 

adequate physical security of controlled 

substances. ALJ–1, at 2. Further, the 

DEA was unable to conduct an audit 

during the inspection because of the 

HMC’s recordkeeping deficiencies. ALJ– 

1, at 2. On April 3, 2013, the HMC 

entered a settlement agreement with the 

United States based on these violations. 

ALJ–1, at 2. By the terms of the 

settlement agreement, the HMC agreed 

to pay a civil monetary penalty, but 

denied culpability or wrongdoing. ALJ– 

1, at 2. 

5. On October 14, 2014, the DEA 

discovered that the HMC failed to: 

maintain complete and accurate records 

of each controlled substance received, 

sold, and delivered; conduct a biennial 

inventory and an inventory of 

buprenorphine; preserve 222 Forms; 

indicate the date of receipt of 222 

Forms; execute a power of attorney 

authorizing an alternate person to sign 

222 Forms; and complete accurate daily 

dispensing logs, in violation of 21 C.F.R. 

1304.21(a), 1304.11(c), 1304.11(b), 

1305.17(a), 1305.13(e), 1305.05, and 

1304.24(a). ALJ–1, at 3. On that date, the 

DEA found variances in the HMC’s 

controlled substance inventory. ALJ–1, 

at 3. 

STIPULATIONS OF FACT 

The Government and the Respondent 

stipulated to the following facts: 

1. Respondent is registered with the 

DEA as a narcotic treatment program in 

Schedules II and III under DEA 

Registration RH0208567 at 4608 Main 

Street, Houston, Texas 77002. 

2. DEA Registration Number 

RH0208567 expires by its terms on 

October 31, 2016. 

WITNESSES 

The Government presented its casein-chief through the testimony of six 

witnesses. First, the Government called 

a DEA Unit Chief (‘‘Unit Chief’’). Tr. 27– 

84. The Unit Chief previously worked in 

the DEA’s Houston Division Office for 

approximately eight years. Tr. 28. Along 

with two other DEA investigators, the 

Unit Chief participated in the DEA’s 

inspection of the HMC in 1999. Tr. 28. 

At that time, the Unit Chief was a 

trainee, and the 1999 inspection was 

one of the first methadone clinic 

inspections in which she had 

participated. Tr. 28, 31. The Unit Chief 

assisted with the 1999 inspection by 

counting the HMC’s on-hand inventory 

and by helping with the controlled 

substances audit. Tr. 29, 38–39. The 

Unit Chief also recalled meeting with 

Dr. Ozumba during that inspection, but 

was unsure if anyone else was present 

during that meeting. Tr. 29–30. The Unit 

Chief added up purchase records, 

dispensing records, and the closing 

inventory for the audit’s computation 

chart, Government’s Exhibit (‘‘GE-’’) 30. 

Tr. 80–82. Through the Unit Chief’s 

testimony, the Government 

authenticated and successfully offered 

into evidence GE–28–30 and 32. See Tr. 

27–84. I find all of these exhibits to be 


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accurate, authentic, and meriting 

credibility. 

While I find the Unit Chief to be a 

generally credible witness, several key 

factors detract from her overall 

credibility. First, at the time of the 1999 

inspection, the Unit Chief was a trainee, 

who had not yet attended the DEA 

academy. Tr. 28. Second, during her 

testimony, I sensed that she was 

testifying based upon her experience of 

how DEA conducts inspections, not on 

her specific recollection of what 

happened during the inspection in 

1999. I even addressed that concern on 

the record. Tr. 40–41, 81. Third, she 

testified that Dr. Ozumba was present 

during the inspection, but she was not 

sure if anyone else representing the 

Respondent was there. Tr. 29–30. She 

recalls Dr. Ozumba, in part, because he 

had a ‘‘very deep voice,’’ and she 

attempted to mimic his voice during her 

testimony. Tr. 47. She also testified that 

Dr. Ozumba signed the Notice of 

Inspection in 1999. Tr. 30. Dr. Ozumba, 

however, did not sign the Notice of 

Inspection; it was signed by another 

employee of the HMC who was there. 

Tr. 47; see also GE–28. Furthermore, 

when Dr. Ozumba testified, given the 

Unit Chief’s earlier testimony and 

mimicking, I was struck by the fact that 

Dr. Ozumba does not have a deep voice 

at all. Fourth, the Unit Chief’s testimony 

was internally inconsistent concerning 

whether a closing interview was 

conducted. At first, she testified that she 

participated in a closing interview with 

the owners of the clinic. Tr. 38–39. 

Later, the Unit Chief testified that she 

could not recall if a closing inventory 

had been conducted. Tr. 78. Finally, this 

inspection occurred over seventeen 

years ago. While I find that the Unit 

Chief’s testimony generally was 

forthright and honest, where her 

testimony directly conflicts with the 

testimony of other witnesses, I give the 

Unit Chief’s testimony less weight. 

Second, the Government presented 

the testimony of Latoya Latrese 

McSwain, L.P.N. (‘‘McSwain’’). Tr. 85– 

147. McSwain was employed by the 

HMC as a dosing nurse from January 

2014 through January 2015. Tr. 86, 102. 

McSwain was familiar with the manner 

in which controlled substances were 

inventoried at the HMC. Tr. 112. 

McSwain signed and initialed parts of 

the HMC’s daily dispensing record. See 

Respondent’s Exhibit (‘‘RE-’’) A, at 85, 

91. Along with the HMC’s receptionist, 

McSwain was at the clinic when DEA 

investigators conducted an inspection in 

2014. Tr. 87. Before Dr. Ozumba arrived 

at the HMC during that inspection, the 

DEA Diversion Investigator Case Agent 

(‘‘Case Agent’’) spoke with McSwain. 

Tr. 92, 110. During the inspection, 

McSwain helped thoroughly search the 

HMC for the documents requested by 

DEA. Tr. 89–90. I find McSwain’s 

testimony to be detailed, thorough, 

honest, and internally consistent. 

Therefore, with one exception, I merit 

her testimony as credible in this 

Recommended Decision. I do not credit 

her testimony concerning the time the 

DEA investigators arrived to conduct the 

inspection on October 14, 2014. 

Third, the Government presented the 

testimony of Natalie Benjamin Farr 

Franks (‘‘Franks’’). Tr. 148–79. Franks 

worked for the HMC as a dispensing 

nurse from February 2010 through June 

2012, except for a six-month period in 

which Franks took maternity leave. Tr. 

149–50. As a dispensing nurse, Franks 

handled recordkeeping, administered 

medication, and inventoried the HMC’s 

controlled substances. Tr. 151–52. I find 

Franks’ testimony to be detailed, 

thorough, honest, and internally 

consistent. Therefore, I merit her 

testimony as credible in this 

Recommended Decision. 

Fourth, the Government presented the 

testimony of a DEA Group Supervisor 

(‘‘Group Supervisor’’). Tr. 187–264. The 

Group Supervisor has worked for the 

DEA for about 10 years. Tr. 188. In 

January 2005, the Group Supervisor 

began working as a diversion 

investigator at the DEA’s Houston office. 

Tr. 188. On September 8, 2006, the 

Group Supervisor participated in a 

scheduled inspection of the HMC. Tr. 

192. During that inspection, the Group 

Supervisor observed the physical audit 

of the HMC’s controlled substances and 

provided calculations to create a closing 

inventory, GE–23. Tr. 204–06. Through 

the Group Supervisor’s testimony, the 

Government authenticated and 

successfully offered into evidence GE– 

22–26. See Tr. 187–264. I find all of 

these exhibits to be accurate, authentic, 

and meriting credibility. I also find the 

Group Supervisor’s testimony to be 

detailed, thorough, honest, and 

internally consistent. Therefore, I merit 

her testimony as credible in this 

Recommended Decision. 

Fifth, the Government presented the 

testimony of the Case Agent. Tr. 265– 

610. The Case Agent has worked for the 

DEA as a diversion investigator for six 

years. Tr. 266. The Case Agent 

investigates DEA registrants to verify 

their compliance with the Controlled 

Substances Act, and she has 

participated in over 100 scheduled 

investigations. Tr. 266–67. The Case 

Agent formerly worked in the DEA’s 

Houston office, and she currently works 

in the Miami office. Tr. 266. The Case 

Agent participated in the DEA’s October 

2011 and October 2014 scheduled 

inspections of the HMC. Tr. 271–72. 

Through the Case Agent’s testimony, the 

Government authenticated and 

successfully offered into evidence GE– 

3–6, 8–21, 31, and 33–37. See Tr. 265– 

610. I find all of these exhibits to be 

accurate, authentic, and meriting 

credibility. There is credible evidence of 

record that the Case Agent found 

dealing with the Ozumba’s to be 

frustrating and that she was brusque in 

her dealing with them. There is also 

credible evidence that the Case Agent is 

a professional and well-trained DEA 

investigator. Therefore, I do not find 

that her frustration or brusqueness 

adversely impacts her credibility in this 

case. I find the Case Agent’s testimony 

to be detailed, thorough, honest, and 

internally consistent. Therefore, I merit 

her testimony as credible in this 

Recommended Decision. 

Sixth, the Government presented the 

testimony of Cecilia Ozumba (‘‘Mrs. 

Ozumba’’). Tr. 643–938. The 

Respondent also elicited direct 

examination testimony from Mrs. 

Ozumba. Tr. 813. Mrs. Ozumba was 

educated and trained in clinical 

psychology and chemical dependence 

counseling; she is not educated and 

trained as a regulatory specialist. Tr. 

814, 817, 821, 828. Through Mrs. 

Ozumba’s testimony, the Government 

authenticated and successfully offered 

into evidence GE–7 and 27. See Tr. 643– 

938. Additionally, through Mrs. 

Ozumba’s testimony, the Respondent 

authenticated and successfully offered 

into evidence RE–A, B, pages one 

through four of RE–C, RE–E, G, H, X, Z, 

and BB. 

During her testimony, Mrs. Ozumba 

seemed confused, had difficulty 

recalling pertinent information, and at 

times was evasive, particularly during 

the initial direct examination by 

Government counsel. For example, she 

was confused concerning: who had 

signed the DEA application for the 

HMC; the 1999 inspection; the sequence 

of the 2011 inspection; and how RE–C 

had been created. Tr. 646, 685–89, 750, 

787–99. Confusion persisted throughout 

her first day of testimony, with 

examples too numerous to cite. She was 

not sure of: the number of times the 

HMC had been inspected by DEA; when 

the HMC started using buprenorphine; 

when RE–BB was provided to the 

Government; what documents she 

brought with her to the 2011 informal 

hearing; and whether the DEA 

investigators took documents away from 

the HMC during the 2011 inspection. Tr. 

670, 672, 685–89, 716, 738–39, 754–55. 

I also found her testimony evasive about 

the training she received concerning 


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8With the consent of both parties, the testimony 

of the Respondent’s witness, Sharon Bultron, was 

taken out of order at the Respondent’s request. Tr. 

612. 

9 GE–23 bears Bultron’s signature and reflects that 

Bultron took the inventory during the 2006 

inspection. 

10Liquid methadone is also referred to as LAAM. 

Tr. 30, 79–80. 

11Methadone is a Schedule II controlled 

substance. 21 C.F.R. § 1308.12(c)(15). 

DEA regulations. Tr. 663–69. At times, 

her testimony was internally 

inconsistent, such as when she testified 

that she was not sure if the DEA 

inspectors removed documents from the 

HMC during the 2011 inspection, and 

then later testified that they did, and 

when testifying that Dr. Ozumba was 

both there and not there during the 2011 

inspection. Tr. 754–56. In addition, Mrs. 

Ozumba frequently had trouble finding 

her place on exhibits when being 

questioned by counsel; in fact, to speed 

the process along, I highlighted one of 

the exhibits for her. Tr. 648, 680, 707– 

08, 801–03 (indication of ‘‘pause’’), 833– 

34, 875, 896, 919. While these factors 

detract from Mrs. Ozumba’s overall 

credibility as a witness, I found her to 

be truthful concerning her own medical 

issues, the recordkeeping procedures 

she had in place in the HMC, and her 

belief that the deficiencies related to the 

1997, 1999, and 2006 inspections had 

been ‘‘resolved.’’ Where her testimony 

conflicts with the testimony of other 

witnesses, I give her testimony less 

weight. 

The Respondent presented its case 

through the testimony of four witnesses, 

including Mrs. Ozumba. The 

Respondent presented the testimony of 

a second witness, Sharon Bultron, R.N. 

(‘‘Bultron’’).8 Tr. 612–43. Bultron has 

been a nurse for 30 years and began 

working for the HMC in June 2006; she 

still currently works for the HMC on a 

part-time basis. Tr. 613–14, 623. Bultron 

was present during the 2006 DEA 

inspection. Tr. 629. Bultron testified 

that she did not participate in the 2006 

inventory. Tr. 631. When she examined 

GE–23, however, she concluded that she 

had assisted with the inventory. Tr. 

634–35; see GE–23.9 I find Bultron’s 

testimony to be detailed, thorough, 

honest, and internally consistent. 

Therefore, I merit her testimony as 

credible in this Recommended Decision. 

Third, the Respondent presented the 

testimony of William ‘‘Rusty’’ Garnett 

(‘‘Garnett’’). Tr. 947–1007. Garnett 

testified that he currently works as a 

‘‘glorified administrator’’ for the HMC; 

specifically, he runs the front desk and 

has contact with patients and vendors. 

Tr. 948. Garnett worked for the HMC 

from May 2012 through May 2013, and 

returned to work there in December 

2015. Tr. 949–50. Garnett has always 

worked for the HMC as a part-time 

employee, working six days a week. Tr. 

973. Garnett was not present at the HMC 

during any of the DEA’s inspections. Tr. 

974. Garnett personally receives daily 

dispensing numbers from the 

dispensing nurses and enters those 

numbers into a digital perpetual 

inventory. Tr. 949. Garnett testified that 

he created RE–X, a document that Mrs. 

Ozumba claims to have created in 2006. 

Tr. 935, 963, 1004. I find Garnett’s 

testimony to be detailed, thorough, 

honest, and internally consistent. 

Therefore, I merit his testimony as 

credible in this Recommended Decision. 

Fourth, the Respondent presented the 

testimony of Dr. Amos Ozumba (‘‘Dr. 

Ozumba’’). Tr. 1008–36. Dr. Ozumba is 

a psychotherapist and was the original 

DEA registrant for the HMC. Tr. 1008– 

09. Dr. Ozumba’s testimony was at times 

confusing, internally inconsistent, and 

inconsistent with the testimony of other 

witnesses. For example, Dr. Ozumba 

testified about the DEA’s 2011 

inspection, first saying that he was 

called by McSwain, but the 

Respondent’s counsel pointed out that 

Franks, not McSwain, was the 

dispensing nurse at the HMC at the 

time. Tr. 1009–10. In addition, despite 

several attempts by Respondent’s 

counsel to clarify whether Dr. Ozumba 

was testifying about the 2011 or 2014 

inspection, Dr. Ozumba erroneously 

remained firm that he was testifying 

about the 2011 inspection when, in 

reality, he described details from the 

2014 inspection. Tr. 1009–12. Further, 

Dr. Ozumba testified both that he 

explained to the investigators that his 

wife was sick, that she was present for 

the inspection, and, at a later point, that 

he could not recall if Mrs. Ozumba was 

present. Tr. 1010, 1012, 1027. Dr. 

Ozumba also testified about what the 

DEA inspectors did after he left the 

HMC. Tr. 1012. For these reasons, and 

for further reasons discussed infra, with 

one exception, I do not merit Dr. 

Ozumba’s testimony as credible where it 

conflicts with the testimony of other 

witnesses. The one exception concerns 

his testimony that the closing inventory 

had been taken prior to his arrival at the 

HMC on October 14, 2014. Tr. 1017–18; 

see GE–11 (documenting that the 

closing inventory was taken at 9:15 

a.m.). 

Following the Respondent’s case-inchief, the Government presented the 

testimony of two rebuttal witnesses. 

First, the Government presented the 

testimony of a DEA diversion 

investigator (‘‘DI’’). Tr. 1038–52. The DI 

has worked in the DEA’s Houston office 

for the past five years. Tr. 1039. The DI 

participated in the DEA’s inspections of 

the HMC in 2011 and 2014. Tr. 1039. I 

find the DI’s testimony to be detailed, 

thorough, honest, and internally 

consistent. Therefore, I merit her 

testimony as credible in this 

Recommended Decision, except for the 

following issues: whether McSwain was 

still dosing patients when the DEA 

investigators arrived; and whether a 

closing inventory was taken prior to Dr. 

Ozumba’s arrival at the clinic on 

October 14, 2014. See GE–11 

(documenting that the closing inventory 

was taken at 9:15 a.m.). 

Second, the Government presented 

the testimony of Assistant United States 

Attorney (‘‘AUSA’’) Jill Venezia 

(‘‘Venezia’’). Tr. 1053–71. Venezia has 

been an AUSA in Houston since 1997. 

Tr. 1054. In 2013, Venezia handled a 

case against the Respondent on behalf of 

the United States Attorney’s Office. Tr. 

1054–55. That case concerned the 

HMC’s alleged recordkeeping violations 

discovered during the 2011 inspection. 

Tr. 1055. I find Venezia’s testimony to 

be detailed, thorough, honest, and 

internally consistent. Therefore, I merit 

her testimony as credible in this 

Recommended Decision. 

The Respondent attempted to 

introduce the testimony of a rebuttal 

witness. That witness had attended 

every session of the hearing. I excluded 

the witness, citing the sequestration 

order that I issued pursuant to the 

Respondent’s request at the beginning of 

the hearing. Tr. 1072–73. 

The factual findings below are based 

on a preponderance of the evidence, 

including the detailed, credible, and 

competent testimony of the 

aforementioned witnesses, the exhibits 

entered into evidence, and the record 

before me. 

FACTUAL FINDINGS 

I. Background on the Respondent 

1. The HMC is a narcotic treatment 

program in Houston, Texas. See 

Stipulation (‘‘Stip.’’) 1; GE–1. The HMC 

opened in 1995 or 1996. Tr. 824. When 

the HMC opened, it was a small clinic 

that participated in client referral for job 

retraining. Tr. 825–26. The HMC also 

provided counseling in life skills, stress 

management, and relapse prevention. 

Tr. 825–26. When the HMC first began 

its operations, Mrs. Ozumba did not run 

the clinic. Tr. 824. 

2. The HMC employed a medical 

director, a counselor, dispensing nurses, 

and an office manager. Tr. 826–27. The 

HMC dispensed liquid methadone 10

and methadone diskettes to its 

patients.11 See Tr. 157. The HMC also 


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12Buprenorphine is also known as Suboxone and 

is an agonist-antagonist medication used in opioid 

treatment. Tr. 117. Substances containing 

buprenorphine are classified in Schedule III. 21 

C.F.R. § 1308.13(e)(2)(i). 

13Liquid methadone bottles are not translucent. 

RE–Q. 

14 In this case, exhibits more than 10 years old 

were obtained from archival storage. Tr. 398–401, 

405. 

15The Unit Chief’s testimony that Dr. Ozumba 

signed the Notice of Inspection undermines her 

credibility. Tr. 30. 

dispensed some buprenorphine.12 Tr. 

117. 

3. The HMC’s dosing hours were from 

5:30 a.m. to 9:30 a.m., and the clinic 

closed at 10:00 a.m. Tr. 151, 763–64; cf. 

Tr. 87. The clinic, however, remained 

open for counseling and by appointment 

until 4:00 p.m. Tr. 763–64. 

4. The HMC has consistently followed 

the same general recordkeeping 

procedures since the 1990s. Tr. 845–46. 

The dispensing nurse inventoried the 

controlled substances the HMC had on 

hand each morning. Tr. 626, 844–45. 

The nurse then filled out the 

Respondent’s dispensing log during the 

day and, at the end of the dispensing 

hours, the nurse tallied the log. Tr. 627– 

28, 843. The nurse also inventoried the 

controlled substances in the HMC’s 

controlled substances safe. Tr. 640, 843. 

The physical count of the controlled 

substances had to match the calculated 

inventory count. Tr. 173, 444–45, 843– 

45. The daily dosing records were kept 

in spiral binders. Tr. 841. 

5. The HMC stored its methadone 

diskettes and liquid methadone in a safe 

with a combination lock. Tr. 175. This 

safe was in a room that required a key 

for entry. Tr. 175–76. An alarm system 

was connected to the safe. Tr. 175, 177. 

II. Background on DEA Inspections 

6. A DEA group supervisor schedules 

inspections and audits of registrants. Tr. 

190. Scheduled inspections are 

unannounced because the DEA expects 

registrants to always comply with the 

Controlled Substances Act and its 

implementing regulations, and the 

registrant’s records are always supposed 

to be readily retrievable. Tr. 51, 193. 

Inspections are conducted during 

normal working hours. Tr. 51, 193. 

7. DEA inspections of narcotic 

treatment programs generally follow the 

same basic format as inspections of 

other registrants. Tr. 191. At the 

beginning of a routine inspection, DEA 

investigators ask the registrant’s 

representative to sign a notice of 

inspection. Tr. 51, 268. A notice of 

inspection outlines the registrant’s 

rights and discusses the DEA’s authority 

to inspect the registrant, and normally is 

accompanied by an explanation of what 

the DEA will do during the inspection. 

GE–28; Tr. 30. 

8. The DEA investigators then 

conduct interviews to determine how 

the registrant’s business runs and its 

policies and practices. Tr. 268. The 

investigators determine who has access 

to the registrant’s controlled substances. 

Tr. 268. 

9. During an inspection, registrants 

are asked to produce their controlled 

substance records, such as their biennial 

inventory, purchase records, dispensing 

records, and loss or theft reports. Tr. 

194, 268. Inspections are normally done 

on-site, but, if the DEA takes a 

registrant’s records off-site, the DEA 

provides the registrant with a receipt for 

the records taken. Tr. 241. 

10. The inspection starts with DEA 

investigators obtaining the registrant’s 

biennial audit or any physical inventory 

taken during the audit period; this audit 

or inventory is used by the DEA as a 

beginning inventory. Tr. 195. The DEA 

will then add the registrant’s purchases 

to the inventory. Tr. 195. The total of 

these figures is the amount of controlled 

substances for which the registrant is 

accountable. Tr. 195. 

11. The DEA then conducts a closing 

inventory on the day of the inspection. 

Tr. 195, 268. Distributions, losses, or 

thefts are added to the closing inventory 

count. Tr. 195. This combined total is 

the amount of controlled substances for 

which the registrant can account. Tr. 

195. 

12. If there is a difference between the 

controlled substances that a registrant is 

accountable for and the controlled 

substances that a registrant can account 

for, the DEA reviews its audit and 

calculations to verify that the audit was 

done correctly. Tr. 195–96. When a team 

of DEA investigators conducts an audit, 

all of the investigators count and check 

their counts against each other. Tr. 80– 

81, 196. If, upon further review, a 

difference (or ‘‘variance’’) still exists, 

the registrant is given an opportunity to 

explain the difference. Tr. 196. 

13. It is more difficult to obtain an 

accurate measurement of liquid 

methadone than methadone tablets. Tr. 

63. Liquid methadone bottles may also 

be overfilled by their manufacturers. Tr. 

221, 223, 256–57.13 A small statistical 

variance is expected in measurements of 

liquid methadone. Tr. 63, 220–21. 

14. During an inspection, the DEA 

also evaluates the registrant’s security 

system. Tr. 194, 268–69. To do so, a 

member of the DEA’s inspection team 

will speak on the phone with the 

registrant’s security company while the 

registrant’s security system is 

intentionally breached to ensure that the 

security company receives signals 

triggered by the breach. Tr. 194. 

15. At the end of an inspection, 

investigators normally conduct a closing 

discussion with the registrant to address 

the results of the inspection. Tr. 269; see 

Tr. 670–71 (acknowledging that after 

three of the DEA inspections involved 

in this case, the DEA discussed the 

results of the inspection with Mrs. 

Ozumba). 

III. The 1997 Inspection 

16. The DEA inspected the HMC on 

April 17, 1997. GE–33; 14 see Tr. 401–02. 

Mrs. Ozumba signed the Notice of 

Inspection at that time. GE–33; Tr. 398– 

401. 

17. Government’s Exhibit 34 is a copy 

of the closing inventory from the 1997 

inspection. Government’s Exhibit 35 is 

a copy of the computation chart used 

during the inspection. 

18. DEA investigators found that the 

HMC had a shortage of 16,144 mg of 

methadone tablets (a 1% difference) and 

a shortage of 411 mg/mL of liquid 

methadone (a 7% difference). GE–35; 

see GE–34 (showing that the 

Respondent had 249,975 mg of 

methadone tablets and 100 mg of liquid 

methadone on hand at the time of the 

inspection). 

19. On May 1, 1997, the DEA sent a 

letter of admonition to Mrs. Ozumba. 

GE–36; Tr. 404–05. The letter stated that 

the HMC failed ‘‘to maintain complete 

and accurate records of controlled 

substances . . . . Result[ing] in a 

variance of ¥16,144 (¥1%) Methadone 

and ¥411 (¥7%) LAAM.’’ GE–36. The 

letter directed Mrs. Ozumba to advise 

the DEA about what ‘‘specific steps 

[she] will take to correct the violations.’’ 

GE–36. 

20. On May 21, 1997, Mrs. Ozumba 

wrote a letter to the DEA to identify 

corrective measures she implemented to 

rectify the problems identified in the 

1997 inspection. GE–37; Tr. 407–09, 

675–78. 

21. Mrs. Ozumba accepts 

responsibility for the variances 

discovered in the 1997 inspection. Tr. 

685, 687, 693, 929. 

IV. The 1999 Inspection 

22. On December 6, 1999, at around 

10:00 a.m., the DEA inspected the HMC. 

See GE–28, 29; Tr. 48. At the beginning 

of the 1999 inspection, Emmanuel 

Uchem (‘‘Mr. Uchem’’), the HMC’s 

facility manager, signed a Notice of 

Inspection.15 Tr. 32, 47, 52, 72; see GE– 

28; see also GE–32, at 1 (identifying Mr. 

Uchem as the Respondent’s facility 

manager). Generally, a facility manager 


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16The Unit Chief testified that the quantity of 

methadone diskettes on GE–29 should have been 

641,740, rather than 641,750, which would have 

resulted in an overage of 100,800 mg of methadone. 

GE–29–30; Tr. 55–59. Upon closer examination of 

the exhibit, however, the 641,750 figure is correct. 

The error occurred in the ‘‘Containers X Contents’’ 

column concerning the methadone diskettes, where 

the investigators added 340 to 1410, and entered 

1740 as the sum. Simple addition reveals the 

correct total to be 1750. Thus, the totals in the 

‘‘Containers X Contents’’ column of GE–29 would 

be 624,000 + 16,000 + 1750, which equals 641,750. 

17Column 5 of GE–30 represents the controlled 

substances the HMC had on hand when the DEA 

conducted the inspection. Tr. 37, 40. This number 

is taken from the column on GE–29 labelled 

‘‘Quantity.’’ GE–29. The ‘‘Quantity’’ column of GE– 

29 was determined by multiplying the number of 

controlled substances the Respondent had on hand 

by the strength of the controlled substances. Tr. 55. 

Column 6 of GE–30 was calculated using the 

Respondent’s controlled substance purchases and 

dispensing logs. Tr. 40. Column 8 is the variance 

amount, which represents the difference between 

Column 4 and Column 7. GE–30; Tr. 82. 

18There was a gap in the monthly perpetual 

records due to Mrs. Ozumba’s absence for a family 

vacation. Tr. 878–80; see GE–27. Nonetheless, at 

that time, the HMC’s nurses still conducted opening 

inventories, maintained daily dispensing records, 

and conducted closing inventories each day. Tr. 

878. 

19 If a registrant counts its controlled substances 

every day and records that count in a manner that 

satisfies the Code of Federal Regulations’ biennial 

inventory requirements, that daily inventory is 

considered to be an adequate biennial inventory. Tr. 

246. 

20The purchases reflected on GE–25 are recorded 

under the ‘‘purchases/receipts’’ column of GE–24. 

Tr. 207–08. 

21This equals just one methadone tablet. Tr. 251. 

22But see Tr. 629 (Bultron testifying that, during 

the 2006 inspection, a DEA investigator told her 

that the HMC’s inventory balanced out, but Bultron 

could not recall whether the investigator was a man 

or a woman). 

23Contra Tr. 881–82. 

has access to all documents needed to 

conduct a DEA audit. Tr. 53–54. 

23. After Mr. Uchem signed the 

Notice of Inspection, the DEA 

inventoried the HMC’s liquid 

methadone and methadone diskettes. 

Tr. 30. Government’s Exhibit 29 is a 

copy of the closing inventory. Tr. 33. 

Government’s Exhibit 30 is a copy of the 

computation chart used by the 

investigators during the inspection. Tr. 

36–37. 

24. DEA investigators found that the 

Respondent had an overage of 

100,810 16 mg of methadone diskettes, 

and a shortage of 2,591 mg of liquid 

methadone. GE–30; Tr. 37, 40.17 The 

Unit Chief recalled that the Respondent 

had an overage of one product and a 

deficit of the other, but she could not 

recall which was which. Tr. 30–31. 

25. Throughout the 1999 inspection, 

the employees of the HMC were 

cooperative with the DEA investigators. 

Tr. 54. 

26. It is unclear whether the DEA 

investigators conducted a closing 

interview following the 1999 inspection. 

Compare Tr. 39 (stating that the Unit 

Chief helped conduct a closing 

interview, wherein the DEA discussed 

variances with the Respondent), and Tr. 

74 (stating that there was a closing 

interview after the inspection), with Tr. 

78 (stating that the Unit Chief was 

unsure whether the DEA conducted a 

closing interview after the inspection). 

27. On December 15, 1999, the DEA 

issued a Notice of Hearing to the HMC, 

which informed the HMC that it would 

be the subject of a hearing concerning 

its failure to ‘‘maintain accurate records 

resulting in the following discrepancies: 

Methadone Diskets 40 mg +100,810 

mg[,] + 3.77%[;] LAAM 10 mg/ml 

¥2,591mg[,] ¥3.01%.’’ GE–31; see Tr. 

398–401, 411–13. 

28. On March 6, 2000, Mrs. Ozumba 

signed a Memorandum of 

Understanding (‘‘MOU’’) on the HMC’s 

behalf. GE–32; Tr. 65. The MOU cited 

the HMC for its failure to maintain a 

complete and accurate record of 

Schedule II controlled substances 

received and distributed. GE–32, at 1. 

The MOU did not mention any 

variances found during the December 

1999 inspection. Tr. 68, 875; see GE–32. 

In the MOU, the HMC agreed to 

‘‘maintain a complete and accurate 

record of all Schedule II controlled 

substances received and distributed as 

required by 21 U.S.C. § 827(a)(3) and 21 

C.F.R. § 1304.21(a).’’ GE–32, at 2. 

29. Mrs. Ozumba’s acceptance of 

responsibility for the variances 

discovered in 1999 is unclear. Mrs. 

Ozumba believed that every variance 

discovered after the 1997 inspection had 

been resolved. Tr. 694. While Mrs. 

Ozumba accepted responsibility for the 

variance found in 1999, she also denied 

responsibility for it. See Tr. 685, 689. 

Mrs. Ozumba specifically denied having 

a variance of 100,810 diskettes in 1999, 

stating she has never had a variance that 

large. Tr. 696–97; see GE–30. Mrs. 

Ozumba also testified that she believed 

the 1999 variances had been resolved by 

the MOU. Tr. 697–98. 

V. The 2006 Inspection 

30. Prior to the 2006 inspection, at the 

start of every day, Bultron inventoried 

the controlled substances at the HMC. 

Tr. 626. At the end of each day, she 

tallied up what she had dispensed, 

subtracted that from her starting 

inventory, and conducted a closing 

inventory. Tr. 627–28. Around the time 

of the inspection, the HMC kept 

ongoing,18 systematic daily dispensing 

records. GE–27; Tr. 878. At the time of 

the 2006 inspection, all of the HMC’s 

records were paper files. Tr. 623. 

31. On September 8, 2006, the DEA 

conducted a scheduled inspection of the 

HMC. Tr. 192, 198. Mrs. Ozumba signed 

a Notice of Inspection at 9:55 a.m. that 

day. GE–22; Tr. 200–01. The employees 

of the HMC cooperated with the DEA 

investigators during this inspection. Tr. 

630–31. Likewise, the DEA investigators 

acted professionally. Tr. 634. 

32. During this inspection, the HMC 

had an adequate 19 biennial inventory. 

Tr. 255. 

33. The HMC only provided DEA 

investigators with one 222 Form, which 

was dated June 13, 2006. Tr. 202–03; see 

GE–25. 

34. The DEA inventoried the HMC’s 

liquid methadone and methadone 

diskettes. GE–23; Tr. 205, 219–20. 

Government’s Exhibit 23 is a copy of the 

closing inventory. Tr. 205. 

Government’s Exhibit 24 is a copy of the 

computation chart used during the 

inspection. Tr. 207.20

35. DEA investigators found that the 

HMC had a shortage of 40 mg of 

methadone diskettes 21 (a .01% 

difference) and an overage of 2,954 mg 

of liquid methadone (a 1.9% difference). 

GE–24; see Tr. 207–09.22

36. The methadone diskettes variance 

did not raise concerns that the HMC was 

diverting methadone tablets. Tr. 225. 

However, the liquid methadone 

variance could not be accounted for by 

overfilling, and was not a small or 

expected variance. Tr. 220–21, 230. 

37. Following the inspection, the DEA 

conducted a closing interview with Mrs. 

Ozumba and gave her an opportunity to 

explain both variances. Tr. 250, 881. 

Initially, the variance for methadone 

diskettes was greater than just 40 mg. 

Tr. 251. Mrs. Ozumba produced an 

explanation, which the DEA accepted 

and applied to reduce the variance to 

only 40 mg. Tr. 251. However, Mrs. 

Ozumba did not provide any 

explanation for the overage of liquid 

methadone. Tr. 251. 

38. On September 26, 2006, the DEA 

sent Mrs. Ozumba a letter of admonition 

regarding the 2006 inspection. Tr. 212– 

14; GE–26. The letter of admonition 

alleged that the HMC’s ‘‘[d]ispensing 

records were not maintained in a 

complete and accurate manner’’ 23 as 

required by federal regulations. GE–26; 

Tr. 233. 

39. In response to the letter of 

admonition, Mrs. Ozumba sent a letter 

to the DEA. GE–27; Tr. 238–39. Mrs. 

Ozumba’s letter acknowledged a ‘‘gap in 

monthly perpetual summary records’’ 

due to her brief absence from the HMC. 

GE–27. Mrs. Ozumba indicated that she 

had conducted training, some of which 

surpassed federal requirements, such as 


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24At the hearing, Mrs. Ozumba testified that she 

created a new form, RE–X, to control the 

Respondent’s inventory of controlled substances in 

response to the 2006 inspection. Tr. 931–35. 

However, in GE–27, Mrs. Ozumba mentioned no 

such form. Moreover, Garnett credibly testified that 

he created RE–X in 2012. Tr. 977. Therefore, I do 

not find Mrs. Ozumba’s testimony on this point to 

be credible. 

25 I do not credit Dr. Ozumba’s testimony about 

the 2011 inspection as fully reliable, Tr. 1009–26, 

because it contains several contradictions and 

inconsistencies. E.g., compare Tr. 1009–10 (stating 

that Mrs. Ozumba was not present for the 

inspection), with Tr. 1012, 1014–15 (stating that 

Mrs. Ozumba was present for the inspection); 

compare Tr. 1012 (stating that the HMC produced 

records to the DEA investigators before following 

the investigators to the parking lot), with Tr. 1014 

(stating that the HMC produced records to the DEA 

investigators after following the investigators to the 

parking lot). Insofar as Dr. Ozumba’s testimony 

about the 2011 inspection aligns with other 

witnesses’ testimony about the 2014 inspection, I 

have considered it under the 2014 inspection 

findings, infra. Insofar as Dr. Ozumba’s testimony 

contradicts other witnesses’ testimony about either 

the 2011 or 2014 inspections, I do not merit his 

testimony as credible in this Recommended 

Decision. 

26Respondent’s Exhibit G contains methadone 

diskette dispensing records from October 1, 2011, 

through December 30, 2011. Respondent’s Exhibit 

H contains liquid methadone dispensing records 

from October 14, 2011, through December 31, 2011. 

They were offered in evidence to show the type of 

records the HMC was maintaining around the time 

of the 2011 inspection. Tr. 854–56. 

27Mrs. Ozumba testified, however, that she could 

have done the inspection but did not want to 

because the nurse had already left and because she 

had a doctor’s appointment. Tr. 729 

28 In 2011, Mrs. Ozumba suffered from arthritis 

and chronic pain, as well as some mobility issues. 

Tr. 882, 1009. 

29The Case Agent testified that the DPM decided 

to leave because Mrs. Ozumba would not calm 

down. Tr. 285–86. I do not credit that testimony. 

I find it more likely that the investigators left 

because the interactions between the parties 

remained tense and hostile. 

perpetual inventories.24 GE–27; Tr. 239– 

40. Bultron, however, did not recall the 

HMC implementing any new policies, 

procedures, or trainings after the 2006 

inspection. Tr. 638. 

40. Mrs. Ozumba’s acceptance of 

responsibility for the variance 

discovered in 2006 is unclear. Mrs. 

Ozumba acknowledged the 2006 

variance, but believed that it had been 

resolved. Tr. 930–31. Mrs. Ozumba 

believed that the issues identified 

during the 2006 inspection were 

resolved by her letter, wherein she 

explained that the ‘‘gap in monthly 

perpetual summary records was 

accounted or caused by the Director’s 

brief absence due to a family vacation.’’ 

GE–27; Tr. 690–92; see Tr. 694 

(asserting that all issues after the 1997 

inspection had been resolved). Mrs. 

Ozumba believed that she provided to 

DEA a satisfactory explanation resolving 

the variance within 30 days of the DEA 

inspection. Tr. 699–702. 

41. During the 2006 inspection, the 

HMC provided the DEA with all the 

forms or documents it requested, and 

the HMC was not cited for any errors 

related to its 222 Forms or biennial 

inventory. Tr. 630, 881–82. 

VI. The 2011 Inspection 25

A. Recordkeeping Procedures Before the 

2011 Inspection 

42. Throughout Franks’ employment 

at the HMC, including prior to the 2011 

inspection, Franks counted the 

medicine and balanced the HMC’s 

controlled substance inventory at the 

end of each day. Tr. 152. There were 

occasions when the morning inventory 

count did not match the previous day’s 

closing inventory count. Tr. 153. When 

this happened, Franks would alert Mrs. 

Ozumba. Tr. 153. Likewise, at the end 

of each day, Franks verified that her 

records matched the physical count of 

remaining medication at the HMC. Tr. 

163–64. Franks recorded the amount of 

medication she dispensed each day in a 

file maintained on a computer, printed 

out the information, and put the 

printout in a binder. Tr. 164–66. These 

records were stored in the medication 

room. Tr. 171. Franks followed these 

recordkeeping procedures throughout 

the entire time she worked at the HMC. 

Tr. 171. Mrs. Ozumba emphasized the 

importance of keeping accurate records. 

Tr. 173. 

43. While working for the HMC, there 

were times when Franks ordered 

controlled substances for the 

Respondent’s clinic. Tr. 154. On those 

occasions, Franks would sign her name 

on 222 Forms at Mrs. Ozumba’s 

direction. Tr. 153–54. Respondent’s 

Exhibit BB contains copies of 222 Forms 

that Franks signed between October 

2011 and May 2012. RE–BB, at 1–6, 8; 

Tr. 155–57. 

44. On October 1, 2011, and on 

numerous days until December 31, 

2011, Franks prepared methadone daily 

dispensing records for the HMC. Tr. 

163–70; see RE–G–H.26

B. The Inspection 

45. In October 2011, the DEA 

conducted a scheduled inspection of the 

HMC, with an audit period of one year. 

Tr. 291–92. 

46. Before beginning the inspection, 

the Case Agent checked the Registrant’s 

Information Consolidated System 

(‘‘RICS’’) to see who had signed the 

Respondent’s DEA application. Tr. 277– 

78. RICS documented that, at one point, 

Dr. Ozumba signed the application and, 

at other times, Mrs. Ozumba had signed 

it. Tr. 279. 

47. Mrs. Ozumba signed a Notice of 

Inspection at 9:57 a.m. on October 11, 

2011. GE–3; Tr. 272–73, 276. When the 

DEA investigators arrived to inspect the 

HMC, Mrs. Ozumba asked them to come 

back, stating she did not have the keys 

to the dosing room. Tr. 280.27 Mrs. 

Ozumba indicated that she could not get 

the keys to the dosing room that day. Tr. 

280. The investigators insisted on 

starting the inspection and conducted 

the interview portion of the inspection 

that day. Tr. 281, 290. The investigators 

also confirmed the HMC’s dosing hours 

and informed Mrs. Ozumba that they 

would return in a day or two. Tr. 282. 

48. On October 13, 2011, the 

investigators returned to the HMC 

during a time when Mrs. Ozumba had 

indicated the clinic would be open. Tr. 

282. Upon arrival, the investigators 

found the Respondent’s doors locked. 

Tr. 282. The investigators, however, 

talked with Franks, who was outside of 

the HMC. Tr. 149, 282–83, 731. Franks 

told the investigators that she had 

finished dispensing for the day and had 

to go take a test. Tr. 149, 282–83. The 

DEA investigators were professional and 

told Franks that they had an 

appointment with Mrs. Ozumba. Tr. 

149–50, 158, 162. Franks advised the 

investigators that Mrs. Ozumba was not 

in the building, but Franks contacted 

Mrs. Ozumba by phone and let the DEA 

agents speak with her. Tr. 150, 283, 731. 

During that phone call, Mrs. Ozumba 

stated that she was unable to come to 

the clinic and could not get someone 

else to come to the clinic to complete 

the inspection that day.28 Tr. 283–84, 

731. The DEA investigators returned to 

their office without conducting the 

inspection. Tr. 284. Shortly thereafter, 

Mrs. Ozumba called the DEA office and 

made arrangements to meet at the HMC 

later in the afternoon on that same day. 

Tr. 151, 284. 

49. On the afternoon of October 13, 

2011, DEA investigators, including the 

Houston Office’s diversion program 

manager (‘‘DPM’’), went to the HMC. Tr. 

151, 285. When they arrived, Mrs. 

Ozumba still did not have the keys to 

the dosing room, but Dr. Ozumba 

arrived soon thereafter with the keys. 

Tr. 285. The interaction between the 

DEA investigators and Mrs. Ozumba 

became tense and hostile, and the DPM 

announced that the investigators were 

leaving. Tr. 285–86, 719–26, 734–35.29

Dr. Ozumba, Mrs. Ozumba, and 

Clemente Brown, a counselor, pursued 

the investigators outside of the clinic 

and persuaded the investigators to 

return to complete the investigation. Tr. 

286–88, 1013; cf. Tr. 883. 

50. When Franks observed the 

interactions between the Ozumbas and 


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30Nothing in 21 C.F.R. § 1301.74(l) requires a 

narcotic treatment program to have a panic button 

in its dosing room. Tr. 601. However, the DEA can, 

within its discretion, require that a panic button be 

installed. Tr. 601; see 21 C.F.R. § 1301.74(l). The 

Case Agent did not know whether, prior to October 

2011, anyone had told the HMC that it was required 

to have a panic button in its dispensing room. Tr. 

602. 

31Contra Tr. 751, 886–87, 890. 

32Contra Tr. 751, 890. Mrs. Ozumba testified that 

the HMC maintained a biennial inventory. Tr. 888. 

33The HMC, however, only ordered one strength 

of methadone diskettes (40 mg) and one strength of 

liquid methadone (1 mg/mL). Tr. 924–25. 

34Contra Tr. 722–23, 887, 890, 1012 (Both Dr. 

and Mrs. Ozumba testified that they produced the 

records requested by the DEA investigators, but that 

the investigators refused to look at them). 

35Compare Tr. 734 (stating that the DEA 

investigators left because Mrs. Ozumba refused to 

surrender her DEA registration), with Tr. 1026 

(noting that Dr. Ozumba did not hear the 

investigators ask Mrs. Ozumba to surrender the 

Respondent’s registration). Additionally, Mrs. 

Ozumba testified that the investigators took the 

HMC’s documents with them when they left the 

clinic. Tr. 736–38, 754. I do not find this testimony 

to be credible, particularly because Mrs. Ozumba 

later testified that she was unsure whether the DEA 

took any documents from the clinic. Tr. 755. 

36 I do not credit Mrs. Ozumba’s testimony that 

DEA did not conduct a closing interview 

concerning the 2011 inspection because the security 

system at the HMC was brought up to standards 

about a week after the inspection. Tr. 290–91; see 

also Tr. 901. 

37Mrs. Ozumba testified that no one discussed 

the agreement with her before she signed it. Tr. 710. 

When challenged on that statement, however, she 

admitted that her attorney explained the contents 

of the agreement to her. Tr. 710–11. 

DEA personnel during the inspection, 

the interactions were civil and very 

professional. Tr. 162. However, at times 

throughout this inspection, the 

interactions between Mrs. Ozumba and 

the Case Agent were fairly contentious. 

Tr. 463, 1015–16. 

C. Physical Security 

51. The investigators checked the 

security system at the HMC and 

determined that it was not working 

properly. Tr. 288. The security company 

did not receive signals from various 

security zones in the clinic. Tr. 289, 

533. Additionally, the HMC’s dosing 

room did not have a panic button.30 Tr. 

289, 533. 

D. 222 Forms 

52. The HMC did not produce any 

methadone 222 Forms from the audit 

period as requested by the DEA. Tr. 

313.31 The DEA, however, contacted a 

methadone supplier, BIRI Roxane, 

which produced supplier’s copies of 

five methadone 222 Forms on which the 

HMC had placed orders for methadone. 

Tr. 306–14; see GE–6, at 1–5. 

E. Biennial Inventory and Dispensing 

Logs 

53. The HMC did not produce a 

biennial inventory when requested to do 

so by the DEA. Tr. 477.32

54. The HMC produced its dispensing 

logs upon the DEA’s request. Tr. 477, 

751, 886. Respondent’s Exhibit G 

contains the daily dispensing logs for 

methadone diskettes from October 1, 

2011, to December 30, 2011. Tr. 852–53. 

Likewise, RE–H contains the daily 

dispensing logs for liquid methadone 

from October 14, 2011, to December 31, 

2011. Tr. 854–55. Most of these records 

are from outside of the 2011 

inspection’s audit period, and these 

records do not show the actual 

pharmaceutical name or strength 33 of 

the drugs represented therein. Tr. 854, 

920–24. 

F. Conclusion and Aftermath of the 

Inspection 

55. The DEA investigators conducted 

a closing inventory of methadone at the 

HMC. GE–4, at 1–2; Tr. 300–02, 748–49. 

The DEA did not perform a full audit of 

the HMC’s controlled substance 

inventory because the HMC did not 

produce the records that the DEA 

needed in order to conduct an audit. Tr. 

477.34

56. Although Mrs. Ozumba produced 

records during the inspection, many of 

the records she produced were from 

outside of the audit period. Tr. 289–90. 

57. After two hours, the investigators 

terminated the inspection. Tr. 290.35

The investigators conducted a closing 

interview with Dr. and Mrs. Ozumba 

and told them: (1) which documents 

they had not provided to the 

investigators; and (2) what physical 

security issues the DEA had 

discovered.36 Tr. 290–91. 

58. After the inspection, the DEA 

noted that the HMC committed the 

following violations: failure to maintain 

a biennial inventory; failure to maintain 

complete and accurate records; failure 

to preserve 222 Forms; failure to 

produce adequate power of attorney 

documents; and failure to maintain 

adequate physical security of its 

controlled substance inventory. Tr. 318– 

19. 

59. The DEA gave the HMC a short 

time period to correct its physical 

security issues. Tr. 290. Within a week, 

the HMC corrected those issues. Tr. 291, 

533, 739–40, 901. 

60. Based upon the results of the 

inspection, DEA pursued a civil fine 

from the Respondent. Tr. 291. The 

United States Attorney’s Office handled 

the case against the Respondent, which 

dealt solely with alleged recordkeeping 

violations. Tr. 1055. 

61. The HMC eventually negotiated a 

settlement with the United States 

Attorney’s Office. Tr. 1056–57. Mrs. 

Ozumba signed a ‘‘Stipulated 

Agreement’’ on March 26, 2013, to settle 

the violations found in 2011, but she is 

not sure 37 if she reviewed it before she 

signed it. GE–7; Tr. 708–10. Although 

Mrs. Ozumba believed that she had 

done nothing wrong, she signed the 

Stipulated Agreement because she did 

not have ‘‘a lot of options.’’ Tr. 745. 

62. Paragraph 16 of the Stipulated 

Agreement states that it ‘‘does not 

release Houston Maintenance Clinic 

from DEA administrative liability under 

statute, contract or regulation.’’ GE–7, at 

6. 

63. Paragraph 23 of the Stipulated 

Agreement states, ‘‘The Parties agree 

that this Agreement does not constitute 

evidence or an admission by any person 

or entity, and shall not be construed as 

an admission by any person or entity, 

with respect to any issue of law or fact.’’ 

GE–7, at 7. 

64. Mrs. Ozumba specifically declined 

to accept responsibility for any 

recordkeeping issues discovered in the 

2011 inspection. Tr. 933. Mrs. Ozumba 

believed that any issues concerning the 

2011 inspection had been resolved. Tr. 

694. 

G. Recordkeeping Changes After the 

2011 Inspection 

65. In May 2012, the HMC kept daily 

dispensing logs, but did not use the 

daily inventory form, which Garnett had 

created for the HMC, RE–X. Tr. 963, 

1004. Instead, clinic nurses recorded the 

daily inventory on the daily dispensing 

logs. RE–A; Tr. 963, 1000–01. The HMC 

maintained its perpetual inventory in a 

Microsoft Word document and in paper 

files. Tr. 954, 956. 

66. In 2012, Garnett designed an Excel 

spreadsheet for the HMC for use as a 

perpetual inventory. Tr. 952–59. The 

Excel spreadsheet contained functions 

for automatic addition and subtraction. 

Tr. 956. The first entry under the 

beginning balance for controlled 

substances on the spreadsheet was taken 

from the closing inventory at the last 

DEA inspection. Tr. 957. In 2012, 

Garnett created the spreadsheet format 

for pages one and two of RE–C. Tr. 960, 

982. These pages do not indicate an 

ending balance for any particular day 

except the last day of the month. Tr. 

989, 1001–02. Further, these pages do 

not document any physical inventory of 

the HMC’s controlled substances. Tr. 

989. 

67. Prior to October 2013, Garnett 

formatted the HMC’s daily dosing sheet. 

Tr. 977; RE–A. Garnett automated the 

HMC’s daily dosing sheet; after entries 

are typed into the sheet, data is 


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38For example, on page 91 of RE–B, the daily 

dosing total of 3,500 units of liquid methadone was 

entered into the Excel spreadsheet. Tr. 126–29, 138. 

39 Garnett testified, however, that using RE–C, at 

1, you could not tell what the inventory was on any 

certain day, except for the last day of the month. 

Tr. 989, 1001–02. 

40The DI testified that the DEA investigators 

arrived after dispensing was completed. Tr. 1047. 

In light of conflicting testimony and GE–11, 

showing that the closing inventory was taken at 

9:15 a.m., I do not credit the DI’s testimony on this 

issue. 

41Contra Tr. 1022 (Dr. Ozumba testified that the 

DEA investigator was oppressive, verbally 

combative, and degrading, but he could not detail 

the investigator’s statements). I do not credit Dr. 

Ozumba’s testimony on this issue. 

42Contra Tr. 1040, 1044 (stating that the 

investigators did not conduct any part of the 

investigation, including the inventory, before Dr. 

Ozumba arrived). 

43Contra Tr. 1032 (stating that Dr. Ozumba did 

not talk to his wife during the inspection). 

44 It is unclear whether Mrs. Ozumba was under 

the influence of post-surgery medication at this 

time. Compare Tr. 124 (stating that Mrs. Ozumba 

did not seem to be under the influence of 

medication and seemed to be her normal, spirited 

self), with Tr. 928–29 (stating that Mrs. Ozumba was 

taking tramadol, hydrocodone, prednisone, 

protonix, a muscle relaxer, and anxiety medication 

at that time), and Tr. 716, 772 (stating that she was 

not cognizant and was only pretending to be 

normal). Mrs. Ozumba was cognizant enough, 

however, to ask for the inspection to be conducted 

at a later date. Tr. 324. 

45McSwain testified that Mrs. Ozumba did not 

suggest they look on the computer for documents. 

Tr. 133. Mrs. Ozumba’s testimony on this point was 

contradictory; she first said that she did not tell 

McSwain to look on her computer, but then said 

that she told McSwain to look on her computer. Tr. 

769–72. Further, the Case Agent found McSwain 

creating a document on the computer at Mrs. 

Ozumba’s direction. Tr. 92–94, 326. 

46Tr. 898–99, 901–02. Mrs. Ozumba testified that 

the 222 Forms provided at the hearing in RE–BB 

were maintained in the clinic in a locked cabinet. 

Tr. 898. 

47Mrs. Ozumba testified that there was a biennial 

inventory on a ‘‘backup’’ drive, but McSwain did 

not know about it. Tr. 770. 

automatically generated. Tr. 977, 1004. 

Anything handwritten on the daily 

dosing sheet is entered into the 

electronic dosing sheet by a nurse. Tr. 

978. 

VII. The 2014 Inspection 

68. Prior to the 2014 inspection, 

McSwain and other nurses employed by 

the HMC helped prepare daily 

dispensing records at the clinic. RE–A, 

at 85–318; RE–B, at 91–338; Tr. 103–04. 

These dispensing records were kept in 

an Excel spreadsheet. Tr. 99–100.38

69. McSwain and other employees 

generated a perpetual inventory on a 

monthly basis for the HMC, using the 

daily dosing records. Tr. 114. The 

perpetual inventory was generated by 

totaling all of that month’s daily 

records. Tr. 114. When the HMC 

received orders of controlled 

substances, McSwain increased the 

inventory on the Excel spreadsheet 

accordingly. Tr. 115. On any given day, 

the incoming nurse could look at the 

perpetual inventory and know the prior 

day’s ending inventory. Tr. 129.39

70. While McSwain worked at the 

HMC in 2014, its daily dispensing logs 

always balanced with its monthly 

records. Tr. 115. 

A. Beginning of the Inspection 

71. The DEA inspected the HMC on 

October 14, 2014 with an audit period 

of October 1, 2013, through October 14, 

2014. GE–9, at 1; Tr. 603. 

72. On October 14, 2014, DEA 

investigators came to the HMC before 

9:15 a.m., to conduct an inspection. Tr. 

87, 324; see GE–11. The HMC was still 

dosing when the DEA arrived. Tr. 87– 

88, 324.40 The investigators met with 

McSwain, who was the dispensing 

nurse at that time, and explained that 

they were there to conduct an 

inspection. Tr. 324. 

73. Mrs. Ozumba was not at the clinic 

at the time of the inspection because she 

was recovering from knee surgery and 

was in a great deal of pain. RE–Z; Tr. 88, 

123, 324, 890, 893, 1017, 1035, 1039. 

When Mrs. Ozumba was contacted by 

phone, she requested that the DEA 

investigators come back to conduct the 

inspection in a couple of weeks. Tr. 324. 

74. Throughout the October 2014 

inspection, the DEA investigators were 

professional and were not rude. Tr. 87– 

89, 100.41 Likewise, Dr. Ozumba and the 

Respondent’s employees were 

professional and cooperative throughout 

the inspection. Tr. 1046. 

75. After dosing was concluded, but 

before Dr. Ozumba arrived at the HMC, 

the DEA investigators inventoried the 

controlled substances at the clinic at 

9:15 a.m.42 GE–11; Tr. 88, 343–45, 

1017–18, 1020. 

76. Dr. Ozumba came to the HMC 

between noon and 1:00 p.m. Tr. 88, 

324–25, 765–66, 1009, 1017, 1019, 1040. 

Upon his arrival, Dr. Ozumba signed a 

Notice of Inspection. GE–8; Tr. 321–25, 

1018–19. 

77. The DEA gave Dr. Ozumba a list 

of the documents that the DEA needed 

to review. Tr. 325. Dr. Ozumba had 

access to Mrs. Ozumba’s office, and had 

keys to all of the doors in the HMC and 

Mrs. Ozumba’s office. Tr. 90, 732–33. 

Dr. Ozumba was familiar with where the 

HMC’s records were stored, but he did 

not know where all of the records were 

kept, including the 222 Forms. Tr. 1023. 

78. McSwain, Dr. Ozumba,43 and the 

DEA investigators all spoke to Mrs. 

Ozumba on the phone. Tr. 89, 91, 100, 

325, 373, 431, 536, 716–17, 766–67, 784, 

1039, 1041, 1052.44 McSwain did not 

hear any of the conversations between 

the DEA investigators and the Ozumbas. 

Tr. 110–11, 124, 140–41. Mrs. Ozumba 

made suggestions about where to look 

for the documents that the DEA had 

requested. Tr. 91, 124–25, 716–17, 767– 

68, 784, 1041.45 However, Mrs. Ozumba 

testified that all of the required 

documentation, including daily 

dispensing logs, inventories, and 222 

Forms, was at the HMC at that time. Tr. 

894–95. 

79. Dr. Ozumba testified that he does 

not believe that the 2014 inspection 

would have gone better if Mrs. Ozumba 

had been present for the inspection. Tr. 

1024. He also testified, however, that 

Mrs. Ozumba knew where the 222 

Forms 46 and buprenorphine logs were 

located. Tr. 1025; see also Tr. 91 

(McSwain testifying that when Mrs. 

Ozumba was on the phone, she was 

only suggesting places to look for 

documents.) 

B. Biennial Inventory 

80. The Case Agent requested the 

biennial inventory for the HMC’s 

controlled substances. Tr. 92, 1043. A 

biennial inventory reflects a physical 

count of controlled substances on hand 

on a specific day. Tr. 371. The HMC did 

not provide a biennial inventory. Tr. 

329, 521.47 During the inspection, 

however, Mrs. Ozumba was talking with 

McSwain by phone, instructing her how 

to create a biennial inventory. Tr. 92–93. 

The HMC provided the DEA with 

annual inventories for its methadone 

diskettes and liquid methadone, as well 

as its 2 mg and 8 mg buprenorphine. 

GE–10, at 1–4; Tr. 368–70, 584. 

C. Buprenorphine Inventory 

81. The Case Agent looked for the 

HMC’s buprenorphine (suboxone) 

inventory. Tr. 94, 325–26. McSwain was 

not aware of that inventory; though, she 

did know that the daily dosing records 

of the patients who received 

buprenorphine were kept in a manila 

envelope. Tr. 93–95, 132. The HMC only 

had about three patients who received 

buprenorphine. Tr. 94, 117. After 

requesting the buprenorphine inventory, 

the Case Agent entered the dosing room 

and found McSwain working on a 

computer, creating a buprenorphine 

inventory at Mrs. Ozumba’s direction. 

Tr. 92–94, 326. The Case Agent told 

McSwain to stop what she was doing 

and print off what she had without 

further modifications. Tr. 326. During 

the inspection, the HMC did not 

produce an initial inventory for 

buprenorphine. Tr. 456. 


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48While it is possible to compare RE–E with GE– 

15 to calculate the quantity of controlled substances 

the Respondent received from BIRI-Roxane, it was 

the Respondent’s responsibility to maintain its copy 

of 222 Forms, and to have them readily retrievable 

at the time of the inspection. Tr. 424, 460; see also 

21 C.F.R. §§ 1304.04(f)(2), 1305.17(a). 

49Later, the Respondent submitted this same 

power of attorney form, but it was signed by Dr. 

Orette. RE–F. A comparison of page two of GE–14 

and page one of RE–F reveals that the latter 

document is an alteration of the former. All of the 

handwritten entries on both documents are 

identical. On close examination, it is possible to see 

remnants of Mrs. Ozumba’s signature to the left of 

and below Dr. Orette’s signature. No explanation 

was provided by the Respondent concerning why 

the document was altered. The Respondent did not 

produce RE–F until it was preparing for the hearing 

in this case. Tr. 538. Nonetheless, RE–F represents 

that Dr. Orette was ‘‘authorized to sign the current 

application for registration’’ on the Respondent’s 

behalf. RE–F, at 2; see Tr. 102, 137. Dr. Orette, 

however, has never had the authority to sign the 

Respondent’s DEA registration application. See Tr. 

659. 

D. 222 Forms 

82. The DEA requested 222 Forms 

from the HMC. Tr. 89, 132–33, 1043. 

The HMC provided some 222 Forms to 

the DEA. GE–13, at 1–4; Tr. 353–54. 

However, one 222 Form, dated 

September 9, 2014, was incomplete 

because it does not show the number of 

packages received or the date of receipt. 

GE–13, at 1; Tr. 354–55. Another 222 

Form was signed by Dr. Ozumba, not 

Mrs. Ozumba. GE–13, at 2; Tr. 355. The 

Respondent provided additional 222 

Forms to DEA after the date of the 

inspection, but the DEA did not include 

the information contained on those 

forms in its audit of the HMC because 

they were received after the audit had 

been completed. Tr. 354, 366–67. 

83. The HMC provided the DEA with 

a list of controlled substances that it 

purchased between January 15, 2014 

and September 12, 2014. GE–12; Tr. 

347–49. The DEA obtained a similar list 

from BIRI-Roxane, the Respondent’s 

supplier. GE–15; Tr. 351, 359–63. 

84. The documents in RE–E are 

requisition forms for controlled 

substances, which are not forms that the 

DEA required the HMC to maintain. Tr. 

459–61. In addition, they were not 

produced until this case was being 

prepared for the DEA administrative 

hearing. Tr. 460, 538.48

E. Dispensing Records 

85. The DEA requested the HMC’s 

dosing records. Tr. 135, 1043. The HMC 

provided the DEA with dispensing logs 

for methadone diskettes and liquid 

methadone. Tr. 105, 107, 422, 456–57, 

607, 1043–44; see RE–A–B. 

Respondent’s Exhibit A contains the 

daily dosing logs for methadone 

diskettes from October 1, 2013, through 

October 14, 2014. RE–A; see Tr. 847–48, 

915. Respondent’s Exhibit B contains 

the daily dosing logs for liquid 

methadone from September 30, 2013, to 

October 31, 2014. RE–B; Tr. 849–50. 

86. During the October 2014 

inspection, no dispensing logs were 

provided for buprenorphine, and 

McSwain told the Case Agent that the 

HMC did not have dispensing logs for 

buprenorphine. Tr. 378, 422, 455. While 

RE–AA contains dispensing logs for 

buprenorphine, those logs were not 

provided during the inspection and 

were not produced by the Respondent 

until preparing for the DEA 

administrative hearing. Tr. 461–62, 538. 

F. Variances 

87. The investigators conducted a 

closing inventory as a part of their 

inspection. GE–11. The investigators 

used a computation chart to conduct 

their audit of the HMC’s inventory. GE– 

9, at 1–9; Tr. 375–80. The closing 

inventory indicated that the HMC had 

an overage of 1,200,000 dosage units of 

methadone diskettes and an overage of 

500,251 dosage units of liquid 

methadone. GE–9. The closing 

inventory also indicated that the HMC 

had a shortage of 30 buprenorphine 2 

mg tablets and 175 buprenorphine 8 mg 

tablets. GE–9. These overages and 

shortages were calculated using only the 

HMC’s receipt records; they did not 

incorporate BIRI-Roxane’s (or other 

supplier’s) records, because the audit 

focused on only the Respondent’s 

records. Tr. 379, 421–24, 496–98. 

G. Power of Attorney Forms 

88. The DEA requested the HMC’s 

power of attorney forms. Tr. 96, 1043. 

McSwain knew that a power of attorney 

form had been prepared, but she could 

not find it. Tr. 96. 

89. Dr. Ozumba provided the Case 

Agent with two power of attorney forms. 

Tr. 327–29, 389–92. The first form was 

a blank form that was prepared for 

Austin Orette’s (‘‘Dr. Orette’’) signature. 

GE–21; Tr. 390. Dr. Orette was not 

authorized to sign a power of attorney 

on behalf of the HMC because Dr. Orette 

was not the HMC’s DEA registrant. Tr. 

598–99. The Case Agent explained to 

Dr. Ozumba that Dr. Orette did not have 

the authority to execute a power of 

attorney on behalf of the HMC. Tr. 327, 

390–93. 

90. On the day of the inspection, 

McSwain signed a new power of 

attorney form, which was given to the 

DEA. Tr. 97. Dr. Ozumba gave the Case 

Agent a power of attorney form, 

purportedly signed (without any 

witnesses) on February 8, 2014, with ‘‘C. 

Ozumba’’ written in as the grantor, no 

name written in as the ‘‘attorney-infact,’’ and McSwain’s name signed as 

the ‘‘person granting power.’’ GE–20; Tr. 

328–29, 395–96. 

H. Conclusion and Immediate 

Aftermath of the Inspection 

91. The HMC was unable to provide 

the DEA with all of the documents the 

DEA had requested on the date of the 

inspection. Tr. 91, 94, 105, 107, 132, 

135–36, 329, 437–39, 455, 461–62, 521, 

538, 1023. 

92. At the end of the inspection, the 

investigators took some documents they 

had requested with them and they left 

a receipt, which listed everything that 

the investigators took and the additional 

documents that the DEA needed. Tr. 96, 

1022, 1028–29, 1033. The documents 

the DEA took included some of the 2014 

dispensing logs. Tr. 107–10. 

93. A few days after the inspection, 

but after the DEA’s audit was 

completed, Mrs. Ozumba directed 

McSwain to retrieve a binder from Mrs. 

Ozumba’s office and fax the documents 

contained therein to the DEA. Tr. 98, 

333. McSwain faxed the records that are 

contained in GE–14 to the DEA on 

October 17, 2014. Tr. 333. Some of those 

documents were the documents that the 

DEA investigators requested during the 

inspection, such as a power of attorney 

form and 222 Forms. Tr. 98–99. 

However, most of the faxed documents 

were from outside of the audit period. 

Tr. 333; see GE–14. Only seven of the 

faxed pages were relevant to the DEA’s 

audit. Tr. 340–42; see GE–14, at 3–9. 

94. The power of attorney that was 

faxed to the DEA on October 17, 2014, 

was a form prepared for Dr. Orette’s 

signature; it was signed, however, by 

Mrs. Ozumba, who was the person who 

had authority to sign a power of 

attorney on behalf of the HMC at that 

time.49 GE–14, at 2; Tr. 335, 337–39; see 

Tr. 98–99. 

95. Because of Mrs. Ozumba’s poor 

physical condition, the Case Agent 

attempted to conduct a telephonic 

closing interview with Mrs. Ozumba. Tr. 

330–32. Mrs. Ozumba, however, did not 

cooperate in the telephonic closing 

discussion, so the interview was 

terminated early. Tr. 332. 

96. After the attempted closing 

interview, the DEA notified Mrs. 

Ozumba that an informal hearing would 

be conducted on December 10, 2014. 

GE–17; Tr. 380–82. Mrs. Ozumba was 

notified that the hearing concerned the 

HMC’s failure to: Maintain complete 

and accurate records of each controlled 

substance received, sold, and delivered; 

conduct a biennial inventory; conduct 

an initial inventory of buprenorphine; 

preserve 222 Forms; indicate the date of 


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50Cf. Tr. 716. 

51Contra Tr. 866 (stating that the Respondent 

views this documentation as the ‘‘equivalent’’ of 

222 Forms). 

52Page four of GE–10 contains no entries for 

September and October 2014. 

53 During the inspection, the HMC produced 

different versions of pages one through four of RE– 

C. Tr. 540. 

receipt of 222 Forms; execute a power 

of attorney authorizing an alternate 

person to sign 222 Forms; and 

completely and accurately complete 

daily dispensing logs. GE–17, at 1–2. In 

response, Mrs. Ozumba, on behalf of the 

HMC, sent a letter to the DEA on 

December 4, 2014. GE–18; Tr. 383–84. 

Therein, Mrs. Ozumba requested that 

the hearing be rescheduled to March 11, 

2015, to allow her to obtain legal 

counsel for the HMC, and to 

accommodate Mrs. Ozumba’s 

continuing post-operative medical 

issues. GE–18; Tr. 385. The DEA denied 

the request. GE–19; Tr. 388–89. 

97. Mrs. Ozumba does not believe that 

the HMC committed any violation in 

2014. Tr. 934. Mrs. Ozumba believes 

that any issue found by the DEA has 

been resolved. Tr. 694. Following this 

inspection, Mrs. Ozumba moved all of 

the HMC’s 222 Forms to the clinic’s 

dispensing room. Tr. 934. Mrs. Ozumba 

accepted responsibility for her absence 

during the inspection, but believed that, 

if the DEA were to conduct an 

inspection now, all of the needed 

records would be readily available. Tr. 

934. 

I. Records Produced For the DEA 

Administrative Hearing 

98. During the pendency of this case, 

the HMC provided the DEA with 222 

Forms from the 2014 audit period for 

the first time.50 RE–BB, at 21–29; Tr. 

437–39. One of these 222 Forms was an 

altered copy of a document previously 

given to the DEA during the 2014 

inspection. Tr. 439; compare GE–13, at 

1, with RE–BB, at 29 (reflecting 

alterations on the numbers of packages 

received and the date on which they 

were received). 

99. During the pendency of this case, 

the HMC also provided requisition 

forms for buprenorphine. RE–E; Tr. 867, 

869. However, the HMC was not 

required to maintain these forms. Tr. 

459–61.51 Moreover, RE–E was not 

provided to the DEA until this case was 

already pending. Tr. 460, 538. While it 

is possible to compare RE–E with GE– 

15 to calculate the quantity of controlled 

substances the HMC received from BIRIRoxane, it was the Respondent’s 

responsibility to maintain its copies of 

222 Forms and to retrieve them within 

a reasonable time during the inspection. 

Tr. 424, 460; see also 21 C.F.R. 

1304.04(f)(2), 1305.17(a). 

100. Government’s Exhibit 10, 

provided to the DEA during the 2014 

inspection, see Tr. 584, and 

Respondent’s Exhibit E, provided to the 

DEA during this hearing, both purport 

to report the HMC’s inventory in 2014. 

Compare GE–10, with RE–E. A 

comparison of the two exhibits reveals 

that many of the recorded figures 

therein do not match, including the 

buprenorphine 2 mg, Tr. 559–66; 

compare GE–10, at 3, with RE–E, at 5, 

and the buprenorphine 8 mg, Tr. 566– 

71, compare GE–10, at 4, with RE–E, at 

8. Notably, the two exhibits reflect 

different: beginning balances of 

buprenorphine 2 mg tablets in June 

2014; amounts dispensed in June, 

August, September, and October 2014; 

and ending balances in June through 

October 2014.52 Compare GE–10, at 3–4, 

with RE–E, at 5, 8. 

101. Respondent’s Exhibit C was 

compiled using the HMC’s daily dosing 

reports, but it was not presented to the 

DEA 53 until this case was already 

pending before me. Tr. 540, 794–96, 

863, 866. Pages one and two of RE–C are 

monthly summaries of the HMC’s 

methadone diskette daily dosing 

perpetual inventory. RE–C, at 1–2; Tr. 

116, 857. The beginning balance on this 

form is taken from the last DEA audit. 

Tr. 857–58. This information was 

maintained on Mrs. Ozumba’s backup 

computer drive. Tr. 861–62. Pages three 

and four of RE–C are similar, except 

they concern liquid methadone. RE–C, 

at 3–4; Tr. 117, 863–64. 

102. Government’s Exhibit 10, 

provided to the DEA during the 2014 

inspection, and Respondent’s Exhibit C, 

provided to the DEA during this 

hearing, both purport to report the 

HMC’s inventory. Compare GE–10, with 

RE–C. A comparison of the two exhibits 

reveals that many of the reported figures 

therein do not match, specifically, the 

methadone 40 mg diskettes, Tr. 541–49, 

compare GE–10, at 1, with RE–C, at 1, 

and the liquid methadone, Tr. 551–59, 

compare GE–10, at 2, with RE–C, at 3. 

For example, the two exhibits record 

different: amounts of diskettes 

dispensed in November and December 

2013; ending balances in October 

through December 2013; amounts of 

liquid methadone dispensed in October 

through December 2013; and ending 

balances of liquid methadone in October 

through December 2013. Compare GE– 

10, at 1–2, with RE–C, at 1, 3. 

103. The HMC did not produce 

buprenorphine dispensing logs during 

the inspection. Tr. 455. Respondent’s 

Exhibit AA is the Respondent’s monthly 

buprenorphine dispensing logs for July 

2014 through September 2014. Tr. 117– 

23. These logs were not provided to the 

DEA during the 2014 inspection, and 

were only given to the DEA when this 

case was already pending. Tr. 132, 135– 

36, 461–62, 538. Mrs. Ozumba testified 

that the Respondent’s nurses were 

required to keep daily dosing logs for 

buprenorphine. Tr. 870. 

104. Government’s Exhibit 10, 

Respondent’s Exhibit E, and 

Respondent’s Exhibit AA all contain the 

Respondent’s records for its 

buprenorphine 8 mg tablets. Tr. 592–96, 

869. A comparison of the three exhibits 

reveals several inconsistencies. For 

example, in June 2014, RE–E records 

that the HMC dispensed 104 mg of 

buprenorphine 8 mg tablets, whereas 

RE–AA records that the HMC dispensed 

108 mg of buprenorphine 8 mg tablets, 

and GE–10 records that the HMC 

dispensed only 56 mg of buprenorphine 

8 mg tablets. Compare RE–E, at 8, with 

RE–AA, at 1, and GE–10, at 4. Likewise, 

in September 2014, RE–E records that 

the HMC dispensed 64 mg of 

buprenorphine 8 mg tablets, whereas 

RE–AA records that the HMC dispensed 

68 mg of buprenorphine 8 mg tablets, 

and GE–10 has no entry. Compare RE– 

E, at 5, with RE–AA, at 5, and GE–10, 

at 4. 

VIII. Remedial Measures 

105. After the 2014 inspection, Mrs. 

Ozumba hired an office manager for the 

HMC, Garnett, who is experienced in 

hospital management. Tr. 903. Mrs. 

Ozumba indicated that she would also 

be willing to hire a ‘‘compliance 

specialist.’’ Tr. 904. 

106. In 2015, Garnett returned to work 

at the HMC. Tr. 964. At that time, the 

HMC maintained a perpetual inventory 

in Excel, but the program did not autopopulate. Tr. 964. The HMC now still 

uses Excel to maintain its perpetual 

inventory. Tr. 949. 

107. The HMC still maintains a daily 

dispensing log for each patient. Tr. 951. 

The HMC’s nurses also conduct a 

physical inventory every day and record 

the results on forms like RE–X. Tr. 950– 

52, 965. The data from this daily 

inventory is entered into the perpetual 

inventory using a software program 

called ‘‘Methware.’’ Tr. 952, 966. The 

HMC’s perpetual inventory keeps track 

of the beginning balance, amount 

dispensed, new receipts, any spillage, 

and ending balance. Tr. 953–54. After 

each daily entry is entered into the 

‘‘Methware’’ program, the information 

in that entry cannot be changed. Tr. 967. 


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54Before and during the hearing, I asked both 

parties to state their positions concerning whether 

a public interest analysis applied to this case. See 

Tr. 21–24; see also Tr. 1077–78; ALJ–25. The 

Government argued that a public interest analysis 

does not apply. Tr. 23. The Respondent, however, 

argued that a public interest analysis should apply, 

and that the factors to be considered should 

include: the HMC’s service towards a low-income 

demographic; the HMC’s compliance with state 

laws; and the HMC’s general history of compliance 

with controlled substance laws. Tr. 24. The OSC 

specifically alleges that the Respondent’s COR 

should be revoked under 21 U.S.C. 824(a). 

However, because the Government stated at the 

beginning of the hearing that it did not believe that 

a public interest analysis applied in this case, and 

the OSC also cites 21 U.S.C. 823(g), the Respondent 

was on notice that the Government would argue in 

favor of revocation under 21 U.S.C. 823. 

55The decision in Turning Tide was not 

published in the Federal Register until after the 

conclusion of the hearing in this case. 

56Superior Pharmacy was published in the 

Federal Register on May 18, 2016, before the 

conclusion of the hearing in this case. 

ANALYSIS 

I. Applicable Law 

To receive and maintain a DEA COR, 

a narcotic treatment program must 

‘‘comply with standards established by 

the Attorney General respecting (i) 

security of stocks of narcotic drugs for 

such treatment, and (ii) the maintenance 

of records (in accordance with section 

827 of this title) . . . .’’ 21 U.S.C. 

823(g)(1)(B) (2012).54 A narcotic 

treatment program’s DEA COR ‘‘may be 

suspended or revoked . . . upon a 

finding that the registrant has failed to 

comply with any standard referred to in 

section 823(g)(1) of this title.’’ 21 U.S.C. 

824(a) (emphasis added). Reading these 

two provisions of the Controlled 

Substances Act together, a narcotic 

treatment program’s DEA COR may be 

suspended or revoked because of any 

failure to maintain: (1) the physical 

security of controlled substances; or (2) 

proper records. 21 U.S.C. 823(g)(1)(B), 

824(a); see Turning Tide, Inc., 81 Fed. 

Reg. 47411 (2016).55 As Turning Tide 

discussed in detail, the DEA need not 

analyze the public interest factors when 

deciding whether revocation of a 

narcotic treatment program’s 

registration is appropriate. Turning 

Tide, 81 Fed. Reg. at 47412–13 

(examining the statutory construction of 

21 U.S.C. 823(g)(1) in comparison with 

every other category of registration set 

forth in Section 823). The DEA ‘‘will not 

hesitate to revoke the registration of a 

n[a]rcotic treatment program that fails to 

meet its statutory and regulatory 

obligations to provide adequate security 

and recordkeeping.’’ Queens County 

Med. Soc’y Drug Line, 50 Fed. Reg. 

2098, 2100 (1985). 

A narcotic treatment program’s 

registration may be revoked if the 

narcotic treatment program fails to keep 

its records as required by federal 

regulations. 21 U.S.C. 824(a), 

823(g)(1)(B); see, e.g., Herbert Berger, 

M.D., 52 Fed. Reg. 17645, 17645–46 

(1987). In this case, the Government 

alleged that the HMC committed several 

recordkeeping violations related to: (1) 

receipt and dispensation records of 

controlled substances; (2) 222 Forms; (3) 

retrievable records; (4) biennial and 

buprenorphine inventories; and (5) 

controlled substance variances. 

Additionally, under 21 U.S.C. 824(g), 

narcotic treatment programs are 

required to ‘‘maintain security of stocks 

of narcotic drugs.’’ Queens County, 50 

Fed. Reg. at 2098. In this case, the 

Government alleged that the 

Respondent failed to maintain adequate 

physical security of its controlled 

substances. 

A. Receipt and Dispensation Records 

A narcotic treatment program must 

‘‘maintain, on a current basis, a 

complete and accurate record of each 

substance manufactured, imported, 

received, sold, delivered, exported, or 

otherwise disposed of.’’ 21 C.F.R. 

1304.21(a); see 21 U.S.C. 827(a)(3). 

These records must detail, among other 

things: (1) the types and quantities of 

controlled substances received and 

dispensed; (2) the names and addresses 

of the persons who receive controlled 

substances; (3) the dates of dispensing; 

and (4) the names or initials of the 

persons who dispense or administer 

controlled substances. 21 C.F.R. 

1304.22(c). 

Further, narcotic treatment programs 

must record the controlled substances 

‘‘administered in the course of 

maintenance or detoxification treatment 

of an individual.’’ 21 C.F.R. 1304.03(d). 

Specifically, narcotic treatment 

programs must record, in a dispensing 

log for each controlled substance, the 

following information: 

(1) Name of substance; 

(2) Strength of substance; 

(3) Dosage form; 

(4) Date dispensed; 

(5) Adequate identification of patient 

(consumer); 

(6) Amount consumed; 

(7) Amount and dosage form taken 

home by patient; and 

(8) Dispenser’s initials. 

Id. 1304.24(a)–(b). 

B. 222 Forms 

A registrant must record the quantity 

of controlled substances purchased, 

along with the dates of receipt of the 

substances, on a copy of a 222 Form. 21 

C.F.R. 1305.13(e). In reading the plain 

language of the regulation, the Agency 

recently determined that incomplete 

forms alone could not prove a regulatory 

violation; instead, it required additional 

proof that the purchaser actually had an 

obligation, triggered by the receipt of the 

ordered substances, to complete the 

forms, but neglected to do so. Superior 

Pharmacy I & Superior Pharmacy II, 81 

Fed. Reg. 31310, 31338 (2016).56 In 

other words, the Government must 

prove that the registrant actually 

received the ordered controlled 

substances, but failed to notate it on the 

222 Form. This interpretation was 

reaffirmed by the Agency in Hills 

Pharmacy, L.L.C., 81 Fed. Reg. 49816, 

49842–43 (2016). Additionally, the 

registrant must maintain Copy 3 of each 

executed 222 Form separately from all 

other records of the registrant and make 

available for inspection for two years. 21 

C.F.R. 1305.17(a), (c). 

Generally, only DEA registrants ‘‘may 

obtain and use DEA Form 222 (order 

forms) or issue electronic orders for 

[controlled] substances.’’ 21 C.F.R. 

1305.04(a). This rule has a narrow 

exception: a DEA registrant may 

authorize another person to execute 222 

Forms on the registrant’s behalf by 

properly executing a power of attorney. 

Id. 1305.05(a). The power of attorney 

document must be preserved, ‘‘available 

for inspection,’’ id., and ‘‘executed by 

the person who signed the most recent 

application for DEA registration,’’ id. 

1305.05(d). 

C. Readily Retrievable Records 

A registrant’s records must be readily 

retrievable. Id. 1304.04(f)(1) and (2) 

(requiring narcotic treatment programs 

to maintain records for Schedule II 

substances separately from all other 

records, and records for Schedules III, 

IV, and V controlled substances either 

separately or in ‘‘such form that the 

information required is readily 

retrievable’’); see id. 1304.03(e) 

(requiring mid-level practitioners to 

maintain readily retrievable records). 

Required records and inventories ‘‘must 

be kept by the registrant and be 

available, for at least 2 years from the 

date of such inventory or records, for 

inspection and copying by authorized 

employees of the Administration.’’ Id. 

1304.04(a). The DEA defines ‘‘readily 

retrievable’’ to mean: 

that certain records are kept by 

automatic data processing systems or 

other electronic or mechanized 

recordkeeping systems in such a manner 

that they can be separated out from all 

other records in a reasonable time and/ 

or records are kept on which certain 

items are asterisked, redlined, or in 

some other manner visually identifiable 


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apart from other items appearing on the 

records. 

Id. 1300.01(b). The DEA ‘‘does not 

require that records be ‘instantaneously 

produced.’’’ Edmund Chein, M.D., 72 

Fed. Reg. 6580, 6593 (2007). The records 

must be retrievable in a ‘‘reasonable 

time.’’ Id. In Chein, the DEA briefly 

discussed and interpreted the definition 

of ‘‘reasonable time:’’ 

While what constitutes ‘‘a reasonable 

time’’ necessarily depends on the 

circumstances, under normal 

circumstances[,] if a practice is open for 

business, it should be capable of 

producing a complete set of records 

within several hours of the request. In 

this case, I conclude that on the second 

visit, the clinic’s provision of the 

records within two to three hours 

complied with the regulation but barely 

so. To allow a registrant an even greater 

period of time to produce the records 

would create an incentive for those who 

are engaged in illegal activity to obstruct 

investigations by stalling for time in the 

hopes that DEA personnel would 

eventually give up and leave. 

Id. The DEA has also noted that 

‘‘readily retrievable’’ means producible 

‘‘upon demand of those DEA officials 

charged with conducting inspections.’’ 

Jeffrey J. Becker, D.D.S., 77 Fed. Reg. 

72387, 72406 (2012) (citations omitted); 

see 21 C.F.R. 1304.04(a) (requiring 

records to be maintained for two years 

‘‘for inspection and copying by 

authorized employees of the [DEA]’’). 

D. Biennial and Buprenorphine 

Inventories 

A registrant must record the quantity 

of each controlled substance it 

possesses. 21 C.F.R. § 1304.11(c). A 

registrant must also inventory ‘‘all 

stocks of controlled substances on hand 

at least every two years.’’ Id. A registrant 

must keep all inventory records in an 

accessible form for at least two years 

after the date of the inventory ‘‘for 

inspection and copying by authorized 

employees of the [DEA].’’ Id. 

§ 1304.04(a); see id. § 1304.04(f). Each 

inventory must include ‘‘a complete and 

accurate record of all controlled 

substances on hand on the date the 

inventory is taken.’’ Id. § 1304.11(a). 

This requirement applies to all types of 

controlled substances that a registrant 

possesses. See id. Notably, inventories 

of a narcotic treatment program’s 

Schedule II controlled substances must 

be ‘‘maintained separately from all of 

the records of the registrant.’’ Id. 

§ 1304.04(f)(1). 

E. Variances 

Controlled substance inventories must 

‘‘contain a complete and accurate 

record of all controlled substances on 

hand on the date the inventory is 

taken.’’ Id. § 1304.11(a) (emphasis 

added). Physical inventory counts of 

controlled substances must be accurate. 

See id. § 1304.11(e)(6). Repeated 

variances in controlled substance 

inventories ‘‘manifest[] a casual 

indifference to [a registrant’s] obligation 

to . . . properly account for its supply 

of narcotic drugs.’’ See Queens County, 

50 Fed. Reg. at 2100. Moreover, the 

inability to account for a significant 

number of dosage units creates a grave 

risk of diversion. Med. ShoppeJonesborough, 73 Fed. Reg. 364, 367 

(2008); see also Paul H. Volkman, M.D., 

73 Fed. Reg. 30630, 30644 (2008) 

(finding that ‘‘a registrant’s accurate and 

diligent adherence to this obligation is 

absolutely essential to protect against 

the diversion of controlled substances’’), 

pet. for review denied, 567 F.3d 215, 225 

(6th Cir. 2009). 

F. Physical Security of Controlled 

Substances 

Narcotic treatment programs are 

required to maintain physical security 

controls for controlled substances as set 

forth in 21 C.F.R. § 1301.72. The 

Respondent kept its Schedule II 

controlled substances in a safe. A safe 

used to store Schedule II controlled 

substances must be 

equipped with an alarm system which, upon 

attempted unauthorized entry, shall transmit 

a signal directly to a central protection 

company or a local or State police agency 

which has a legal duty to respond, or a 24- 

hour control station operated by the 

registrant, or such other protection as the 

Administrator may approve. 

21 C.F.R. § 1301.72(a)(1)(iii). Section 

1301.72 does not require a narcotic 

treatment program to install a panic 

button in its dispensing room. See also 

id. § 1301.74(l) (same). 

II. The Respondent’s Alleged Violations 

A. The 1997 Inspection 

The Government alleged that, at the 

time of the 1997 inspection, the HMC 

had committed four violations: (1) 

failing to record the amount of 

controlled substances received; (2) 

failing to keep 222 Forms; (3) failing to 

properly maintain daily dispensing 

records; and (4) having variances in its 

controlled substances supply. ALJ–1, at 

1–2. I find that the Government 

demonstrated that the HMC committed 

only the fourth violation. 

A majority of the Government’s 

evidence regarding the 1997 inspection 

related to the fourth allegation. The 

Government entered evidence showing 

that the HMC had a shortage of 16,144 

mg of methadone tablets and a shortage 

of 411 mg/mL of liquid methadone. GE– 

34–36. Mrs. Ozumba admitted that there 

was a variance in her controlled 

substance inventory at the time of the 

1997 inspection. Tr. 685, 687, 693, 929; 

see GE–37; Tr. 407–09, 675–78. Based 

upon the Government’s undisputed 

evidence, I find that the HMC had a 

shortage of methadone tablets and 

liquid methadone at the time of the 

1997 inspection. Therefore, the 

Government’s allegation to that effect is 

SUSTAINED by a preponderance of the 

evidence, and weighs in favor of 

revoking the Respondent’s COR. 

However, the Government did not 

offer any evidence demonstrating that 

the HMC committed the first three 

alleged violations. The Government 

argued that GE–33–37 showed that the 

HMC committed the first three alleged 

violations. See ALJ–27, at 3. However, 

these exhibits only offer evidence 

supporting findings that: (1) the HMC 

had a variance; and (2) that variance 

was due to some unidentified deficiency 

in the HMC’s records. See GE–34–37. 

The Government did not enter any 

evidence about the HMC’s receipt 

records or 222 Forms from the 1997 

inspection. Therefore, the Government’s 

allegations that the HMC failed to record 

the amount of controlled substances 

received and failed to keep 222 Forms 

are NOT SUSTAINED. 

Likewise, the Government did not 

discuss any inadequacies in the HMC’s 

dispensing record. The Government did 

not enter any evidence specifically 

showing that the HMC’s daily 

dispensing records were inadequate at 

the time of the 1997 inspection. There 

are numerous possible explanations for 

how the HMC could have had a shortage 

of liquid methadone and methadone 

diskettes. One possible explanation is 

that the HMC failed to accurately record 

its dispensing in its daily dispensing 

log. However, that is only a possible 

explanation, supported by inference 

rather than substantial evidence. The 

Government did not allege that, 

generally, the HMC’s receipt and 

dispensing logs were inaccurate; rather, 

it alleged that, specifically, the HMC 

failed to properly maintain daily 

dispensing logs. Therefore, the 

Government’s allegation that the 

Respondent failed to properly maintain 

daily dispensing records in 1997 is NOT 

SUSTAINED. 

B. The 1999 Inspection 

The Government alleged that, at the 

time of the 1999 inspection, the HMC 


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57Unlike the Government’s specific 

recordkeeping allegation concerning the 1997 

inspection, the 1999 allegation concerning 

recordkeeping errors is a general allegation. 

58See Tr. 251 (indicating that this amount is the 

equivalent of one methadone tablet). 

59The Government failed to distinguish between 

222 Forms, discussed in the third allegation, and 

receipt records, discussed in the fourth allegation. 

Therefore, I consider the third allegation to address 

whether the 222 Forms were properly preserved 

and the fourth allegation to address whether the 222 

Forms were properly completed. 

committed two violations: (1) failing to 

maintain complete and accurate records 

of Schedule II controlled substances 

received and dispensed; and (2) having 

variances in its controlled substances 

supply. ALJ–1, at 2. I find that the 

Government showed, by a 

preponderance of the evidence, that the 

HMC committed both violations. 

The Government entered a closing 

inventory and a computation chart from 

the 1999 inspection, which showed that 

the HMC had an overage of 100,810 mg 

of methadone diskettes and a shortage of 

2,591 mg of liquid methadone. See GE– 

29–30; Tr. 37, 40; see also GE–31; Tr. 

398–401, 411–13. These documents 

were corroborated by the Unit Chief’s 

credible testimony that she personally 

recalled an overage of one of the 

Respondent’s controlled substances and 

a deficit of the other. Tr. 30–31. While 

Mrs. Ozumba signed an MOU on behalf 

of the HMC in March of 2000, which 

cited the HMC for its failure to maintain 

a complete and accurate record of 

Schedule II controlled substances 

received and distributed, the MOU did 

not clearly admit or deny that there was 

a variance at the time of the 1999 

inspection. See Tr. 685, 689, 696–98; see 

also GE–32. At the hearing, Mrs. 

Ozumba accepted responsibility for the 

variance found in 1999, and then denied 

responsibility for it. See Tr. 685, 689. 

She subsequently went on to 

specifically deny having a variance of 

100,810 mg of diskettes in 1999, stating 

that she has never had a variance that 

large. Tr. 696–97; see GE–30. I find that 

the closing inventory, computation 

chart, and the Unit Chief’s testimony, 

when considered cumulatively, show 

that the HMC had significant variances 

in its controlled substances supply at 

the time of the 1999 inspection. 

Therefore, the Government’s allegation 

to that effect is SUSTAINED. By logical 

inference, because the HMC had a 

variance in its controlled substance 

supply, the HMC’s records were not 

accurate.57 Therefore, the Government’s 

allegation that the HMC failed to keep 

complete and accurate records of the 

Schedule II controlled substances it 

received and dispensed is SUSTAINED, 

and weighs in favor of revoking the 

Respondent’s COR. 

C. The 2006 Inspection 

The Government alleged that, at the 

time of the 2006 inspection, the HMC 

committed two violations: (1) failing to 

keep and maintain daily dispensing logs 

of controlled substances; and (2) having 

variances in its controlled substances 

supply. ALJ–1, at 2. I find that the 

Government showed, by a 

preponderance of the evidence, that the 

HMC committed only the second 

violation. 

The Government entered a closing 

inventory and computation chart from 

the 2006 inspection showing that the 

HMC had a shortage of 40 mg 58 of 

methadone tablets and an overage of 

2,954 mg of liquid methadone. GE–23– 

24; Tr. 224. The methadone diskettes 

variance did not raise concerns that the 

HMC was diverting methadone tablets; 

however, the liquid methadone variance 

could not be accounted for by 

overfilling and was not a small or 

expected variance. Tr. 220–21, 225, 230. 

Moreover, while Mrs. Ozumba provided 

DEA with an explanation regarding the 

variance for the methadone diskettes, 

which resulted in a reduction of the 

variance to 40 mg, she did not provide 

any explanation for the overage of liquid 

methadone. Tr. 251. Furthermore, the 

Group Supervisor testified that she 

personally observed the count of the 

HMC’s controlled substances, that the 

count was recorded in the computation 

chart, and that the computation chart 

was accurate. Tr. 205–11. The Group 

Supervisor also specifically mentioned 

in her testimony that there was a 

variance, and Mrs. Ozumba specifically 

acknowledged that there was a variance. 

Tr. 220, 250–51, 930; see Tr. 699–702. 

It is important to note that Mrs. 

Ozumba’s acceptance of responsibility 

for the variance discovered at the time 

of the 2006 inspection was unclear. She 

acknowledged the variance, but 

believed that it had been resolved by her 

letter explaining the gap in the monthly 

perpetual summary records. Tr. 930. I 

find that the closing inventory, 

computation chart, Group Supervisor’s 

testimony, and Mrs. Ozumba’s 

ambiguous acceptance of responsibility, 

when considered cumulatively, show 

that the HMC had variances in its 

controlled substances supply at the time 

of the 2006 inspection. Therefore, the 

Government’s allegation to that effect is 

SUSTAINED, and weighs in favor of 

revoking the Respondent’s COR. 

However, the Government did not 

enter any evidence specifically showing 

that the HMC’s daily dispensing records 

were inadequate at the time of the 2006 

inspection. In fact, the record evidence 

establishes that the HMC produced all 

of the forms or documents requested by 

the DEA in 2006. Tr. 630. There are 

numerous possible explanations for how 

the HMC could have had a shortage of 

one methadone diskette and an overage 

of liquid methadone. One possible 

explanation is that the HMC failed to 

accurately record its dispensing in its 

daily dispensing log. However, that is 

only a possible explanation, supported 

by inference rather than substantial 

evidence. The only mention of alleged 

errors in the daily dispensing records 

was in the letter of admonition sent to 

the HMC, GE–26, which, standing alone, 

does not prove that the HMC’s 

dispensing logs were errant. The 

Government has not entered evidence 

showing any specific defects in the 

HMC’s dispensing logs, and has not 

entered copies of the HMC’s dispensing 

logs to support its allegation. In fact, the 

evidence before me indicates that the 

HMC, up until the time of the 2006 

inspection, kept meticulous daily 

dispensing records. GE–27; Tr. 626–28, 

878. The Government failed to show, by 

a preponderance of the evidence, that 

the HMC failed to maintain daily 

dispensing records. Therefore, the 

Government’s allegation to that effect is 

NOT SUSTAINED. 

D. The 2011 Inspection 

The Government alleged that, at the 

time of the 2011 inspection, the HMC 

had eight violations: (1) failing to 

provide records in a timely manner; (2) 

failing to conduct a biennial inventory; 

(3) failing to preserve 222 Forms for two 

years; (4) failing to maintain complete 

and accurate records of each controlled 

substance received; 59 (5) allowing an 

unauthorized person to sign 222 Forms; 

(6) failing to execute a power of attorney 

to allow an unauthorized person to sign 

222 Forms; (7) failing to ‘‘completely 

and accurately complete’’ daily 

dispensing logs; and (8) failing to 

maintain adequate physical security of 

controlled substances. ALJ–1, at 2. I find 

that the Government showed, by a 

preponderance of the evidence, that the 

HMC committed the first, second, third, 

part of the fourth, and eighth violations. 

There is significant disagreement 

between the parties over whether the 

HMC produced its records in a timely 

manner during the 2011 inspection. I 

find that the HMC did not produce these 

records ‘‘upon demand,’’ Becker, 77 

Fed. Reg. at 72406, or within a 

‘‘reasonable time,’’ Chein, 72 Fed. Reg. 

at 6593. The HMC had several days to 

locate the required documents and make 


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60Although the Federal Rules of Evidence do not 

govern DEA administrative hearings, they can 

provide useful guidance ‘‘where they do not 

conflict with agency regulations.’’ Rosalind A. 

Cropper, M.D., 66 Fed. Reg. 41040, 41041 (2001) 

(citation omitted). 

61A layman’s review of the signatures, however, 

finds them to share similarities with Mrs. Ozumba’s 

signature. Compare GE–6, with GE–3, 27, 32, 33. 

62 Importantly, Franks did testify that she was 

allowed to sign 222 Forms on behalf of the 

Respondent. Tr. 153. Franks did not testify as to 

when she was allowed to do so. However, the 

evidence shows that Franks signed several 222 

Forms after the 2011 inspection. See RE–BB, at 1– 

6, 8; Tr. 155–57. Therefore, I find that Franks’ 

testimony, standing alone, does not constitute 

substantial evidence that an unauthorized person 

was signing 222 Forms during the audit period of 

the 2011 inspection. 

them available for inspection, and still 

failed to do so. ‘‘To allow a registrant an 

even greater period of time to produce 

the records would create an incentive 

. . . to obstruct investigations by 

stalling for time in the hopes that DEA 

personnel would eventually give up and 

leave.’’ Chein, 72 Fed. Reg. at 6593. 

The Respondent contends that it 

provided all required documents to the 

Case Agent, who refused to look at those 

documents for an unknown reason. 

ALJ–27, at 4–5. I do not find this 

position, supported by Mrs. Ozumba’s 

testimony, Tr. 722–23, 887, 890, 1012 

(Dr. Ozumba), to be credible for three 

reasons. First, it makes little sense that 

DEA investigators would go to the HMC 

on two separate days to conduct an 

investigation, and on the second day 

come back into the HMC after having 

left, only to refuse to examine 

documents that Mrs. Ozumba claims 

were provided to the investigators. 

Second, the Case Agent credibly 

testified that the Ozumbas did not 

provide the necessary documentation, 

despite the DEA investigators’ attempts 

to work with the Ozumbas for over two 

hours. Third, Mrs. Ozumba felt it 

necessary to enter into a settlement 

agreement with the United States 

Attorney’s Office when the HMC was 

civilly charged for its alleged 

recordkeeping violations. See Tr. 1055– 

57. 

The Government attempts to establish 

liability on the part of the HMC through 

the use of the ‘‘Stipulated Agreement’’ 

Mrs. Ozumba signed on March 26, 2013. 

GE–7; ALJ–27, at 6–7. Based upon the 

results of the 2011 inspection, the DEA 

pursued a civil fine from the 

Respondent. Tr. 291. The United States 

Attorney’s Office handled the case 

against the Respondent, which dealt 

solely with alleged recordkeeping 

violations. Tr. 1055. The HMC 

eventually negotiated a settlement with 

the United States Attorney’s Office. Tr. 

1056–57. 

Federal Rule of Evidence 408 

prohibits the use of a settlement 

agreement to prove or disprove the 

validity of a claim.60 Fed. R. Evid. 

408(a). ‘‘It is well-established that 

statements made for purposes of 

settlement negotiations are 

inadmissible, and Rule 408 of the 

Federal Rules of Evidence extends the 

exclusion to completed compromises 

when offered against the compromiser.’’ 

Playboy Enters., Inc. v. Chuckleberry 

Publ’g, Inc., 486 F. Supp. 414, 423 n.10 

(S.D.N.Y. 1980) (citation omitted). 

Because settlement agreements may not 

be used to establish liability, the 

Government cannot rely on the 

Stipulated Agreement to prove that the 

Respondent committed recordkeeping 

violations in 2011. Moreover, even if 

Federal Rule of Evidence 408 did not 

apply, the Stipulated Agreement 

specified that it ‘‘does not constitute 

evidence or an admission by any person 

or entity, and shall not be construed as 

an admission by any person or entity, 

with respect to any issue of law or fact.’’ 

GE–7, at 7. 

Settlement agreements, however, may 

be admitted for a purpose other than to 

establish liability. Fed. R. Evid. 408(b); 

see Manko v. United States, 87 F.3d 50, 

54–55 (2d Cir. 1996). Therefore, use of 

the Stipulated Agreement in this case 

has been limited to establishing that 

such an agreement existed between the 

HMC and the DEA and that the HMC 

knew of alleged recordkeeping 

violations found in 2011. 

Mrs. Ozumba did not provide any of 

the HMC’s records to the DEA on the 

first day of the inspection, and she did 

not provide any records for several 

hours on the second day of the 

inspection. Tr. 280–81. Even when Dr. 

Ozumba brought the keys to unlock the 

dosing room on day two, the HMC did 

not produce any 222 Forms from the 

audit period, even though the HMC 

should have had five 222 Forms. Tr. 

306–14. The HMC also did not produce 

a biennial inventory. Tr. 477. During the 

inspection, the HMC was even unable to 

produce the records that the DEA 

needed to conduct an audit. Tr. 477. 

Considering these circumstances in 

their totality, I find that the HMC did 

not, at the time of the inspection, 

provide all of the required documents to 

the DEA investigators. Because the HMC 

was unable to produce some of its 

records over the course of several days 

during the 2011 inspection, the 

Government’s allegation that the 

Respondent failed to provide records in 

a timely manner is SUSTAINED, and 

weighs in favor of revoking the 

Respondent’s COR. 

I also find that the HMC did not 

conduct a biennial inventory. Although 

the DEA investigators requested such an 

inventory from the HMC, the HMC did 

not provide one. Tr. 477. Because I find 

the Case Agent’s testimony on this point 

to be credible for the reasons discussed 

supra, the Government’s allegation that 

the Respondent did not conduct a 

biennial inventory is SUSTAINED, and 

weighs in favor of revoking the 

Respondent’s COR. 

The HMC did not produce any of its 

222 Forms from the audit period upon 

the DEA investigators’ request, even 

though the HMC should have had five 

222 Forms from that period. Tr. 306–14; 

see GE–6, at 1–5. Because I find the Case 

Agent’s testimony on this point to be 

credible for the reasons discussed supra, 

the Government’s allegation that the 

Respondent did not preserve its 222 

Forms is SUSTAINED, and weighs in 

favor of revoking the Respondent’s COR. 

However, because the Respondent did 

not provide any 222 Forms, the 

Government cannot show that the HMC 

failed to properly complete such forms. 

Moreover, the Government did not enter 

any evidence demonstrating that the 

HMC failed to properly complete its 

receipt records. Therefore, the 

Government’s allegation that the 

Respondent failed to properly complete 

222 Forms is NOT SUSTAINED. 

The Government was, however, able 

to obtain the Supplier’s Copy of the 

HMC’s 222 Forms from the audit period, 

which are presented in GE–6. Tr. 312– 

15. The signatures on these forms are 

not legible.61 The Government did not 

offer any evidence regarding whose 

signature appeared on the forms in GE– 

6. See Tr. 309. Moreover, it is unclear 

from the record whether Dr. Ozumba or 

Mrs. Ozumba had e-signature authority 

for the Respondent during the 2011 

inspection’s audit period. See Tr. 279. 

These were the only 222 Forms entered 

into evidence from the audit period. 

Because it is unclear who signed the 

forms, it is equally unclear whether 

such person was authorized to sign 222 

Forms. Therefore, the Government’s 

allegations that the Respondent allowed 

an unauthorized person to sign 222 

Forms, and failed to execute a power of 

attorney to allow such person to do so, 

are both NOT SUSTAINED.62

The record indicates that the HMC 

did keep daily dispensing logs. Franks 

testified that she recorded into a 

computer file the amount of medication 

she dispensed each day, printed out that 

information, and put that information in 

a binder that was stored in the 

medication room. Tr. 163–71; see, e.g., 

RE–G–H. Additionally, the record 


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63For methadone diskettes, the HMC ordered 40 

mg, and for liquid methadone, the HMC ordered 1 

mg/mL. Tr. 924–25. 

64The Government discussed the fact that the 

HMC’s dosing room did not have a panic button 

during the 2011 inspection. Tr. 289, 533. However, 

narcotic treatment programs are not required by 

federal regulations to have panic buttons in their 

dosing rooms. See generally 21 C.F.R. 1301.72; see 

also id. § 1301.74(l); Tr. 601–02. Thus, to the extent 

that the Government alleges that the HMC failed to 

maintain physical security of its controlled 

substances by not installing panic buttons in its 

dosing room, that allegation is NOT SUSTAINED. 

65 In its case, the Government failed to distinguish 

between receipt records, discussed in the first 

allegation, and 222 Forms, discussed in the fourth 

allegation. Therefore, I consider the first allegation 

to address whether the 222 Forms were properly 

completed, and the fourth allegation to address 

whether the 222 Forms were properly preserved. 

66Unlike the Government’s specific 

recordkeeping allegation concerning the 1997 

inspection, the 2014 allegation concerning 

recordkeeping errors is a general allegation. 

shows that the Respondent produced its 

dispensing logs to the DEA upon the 

investigators’ request, but the 

Government did not introduce into 

evidence any of those logs concerning 

the one-year audit period. Tr. 291–92, 

477, 751, 886. 

The HMC offered evidence of the type 

of dispensing records it was maintaining 

around the time of the 2011 inspection. 

Respondent’s Exhibit G contains the 

daily dispensing logs for methadone 

diskettes from October 1, 2011, to 

December 30, 2011. Tr. 852–53. 

Likewise, RE–H contains the daily 

dispensing logs for liquid methadone 

from October 14, 2011, to December 31, 

2011. Tr. 854–55. Most of the records 

contained in RE–G are from outside of 

the 2011 inspection’s audit period, and 

the records do not show the actual 

pharmaceutical name of the drug 

dispensed. Tr. 854, 920–24. Rather, they 

show that ‘‘DRT’’ tablets were 

dispensed, and they also record the 

strength in milligrams. RE–G. All of the 

records contained in RE–H are from 

outside of the 2011 inspection’s audit 

period, and the records do not show the 

actual pharmaceutical name or strength 

of the drugs represented therein. Tr. 

854, 920–24. Rather, they show that 

liquid ‘‘LMT’’ was dispensed and the 

dosage dispensed in milligrams. RE–H; 

Tr. 854, 923–24. 

Here, the Government has failed to 

present substantial evidence to show 

that the HMC failed to ‘‘completely and 

accurately complete the daily 

dispensing logs.’’ ALJ–1, at 2. In fact, 

the Government presented no 

documentary evidence from the audit 

period to document the alleged failure. 

At the hearing, the Government 

attempted to demonstrate shortcomings 

in RE–G and RE–H because they did not 

list the pharmaceutical name of the 

drugs dispensed or the strength. Tr. 

920–24. I find the Government’s 

questioning unconvincing for several 

reasons. First, Mrs. Ozumba testified 

that RE–G and RE–H were not the only 

dosing sheets; they represent a general 

daily dispensing sheet, and the HMC 

also used an individualized sheet. Tr. 

922. Second, there is no requirement in 

21 C.F.R. 1304.24(a) that the dispensing 

log specifically list the pharmaceutical 

name. Here, it is absolutely clear that 

the DEA investigators understood the 

terms DRT and LMT, and in fact, Mrs. 

Ozumba testified that she sometimes 

ordered liquid methadone using the 

term LMT. Tr. 919–20. Third, it is clear 

from the record that the HMC only 

ordered one strength of each form of 

methadone it used,63 and the DEA 

investigators were well aware of that. 

Tr. 924–25. Finally, the strength of the 

dosage of the DRT is contained in the 

general dispensing sheets in RE–H, 

which lists the dosage in milligrams. 

See, e.g., Tr. 917–18. Since the 

administrative record contains no 

dosing sheets for the audit period of the 

2011 inspection, with the exception of 

pages one through eleven of RE–G, and 

since I find that those pages generally 

comply with the requirements of 21 

C.F.R. 1304.24(a), I find that the 

Government has not met its burden in 

demonstrating that the HMC failed to 

completely and accurately complete the 

daily dispensing logs. Therefore, the 

Government’s allegation that the 

Respondent failed to ‘‘completely and 

accurately complete’’ daily dispensing 

records is NOT SUSTAINED. 

Finally, concerning the 2011 

inspection, the HMC’s security system 

was not working properly at the time of 

the inspection because the security 

company did not receive signals from 

various security zones in the clinic. Tr. 

288–89, 532–33. While the HMC 

corrected these security issues within a 

week of the inspection, Tr. 290–91, 533, 

739–40, 901, the regulations require a 

narcotic treatment program’s controlled 

substance safe to be ‘‘equipped with an 

alarm system which, upon attempted 

unauthorized entry, shall transmit a 

signal directly’’ to its security company. 

21 C.F.R. 1301.72(a)(1)(iii). The 

evidence shows that the HMC’s system 

did not transmit this signal directly 

during the 2011 inspection. Therefore, 

the HMC’s system did not comply with 

the requirements of 21 C.F.R. 1301.72, 

and the Government’s allegation that the 

Respondent failed to maintain adequate 

physical security of its controlled 

substances is SUSTAINED,64 and 

weighs in favor of revoking the 

Respondent’s COR. 

E. The 2014 Inspection 

The Government alleged that, at the 

time of the 2014 inspection, the 

Respondent had committed eight 

violations: (1) failing to maintain 

complete and accurate records of 

controlled substances received, sold, 

and delivered; (2) failing to conduct a 

biennial inventory; (3) failing to conduct 

an inventory of buprenorphine; (4) 

failing to preserve 222 Forms for two 

years; 65 (5) failing to indicate the date 

of receipt of 222 Forms; (6) failing to 

execute a power of attorney authorizing 

an alternate person to sign 222 Forms; 

(7) failing to completely and accurately 

complete daily dispensing logs; and (8) 

having a variance in its controlled 

substance inventory. ALJ–1, at 3. I find 

that the Government showed, by a 

preponderance of the evidence, that the 

HMC committed the first, third, fourth, 

sixth, and eighth violations. 

The Government entered into 

evidence a closing inventory and a 

computation chart from the 2014 

inspection, which showed that the HMC 

had an overage of 1,200,050 dosage 

units of methadone diskettes, an overage 

of 500,251 dosage units of liquid 

methadone, a shortage of 30 

buprenorphine 2 mg tablets, and a 

shortage of 175 buprenorphine 8 mg 

tablets. GE–9, 11; Tr. 375–80. I find that 

the closing inventory, computation 

chart, and the testimonies of McSwain 

and the Case Agent, when considered 

cumulatively, show that the HMC had 

variances in its controlled substances 

supply at the time of the 2014 

inspection. By logical inference then, 

because the Respondent had a variance 

in its controlled substance supply, the 

Respondent’s records were not accurate, 

particularly since the overages and 

shortages were calculated using the 

HMC’s receipt records.66 Tr. 379. 

Therefore, the Government’s allegations 

that the Respondent failed to maintain 

complete and accurate records of 

controlled substances received, sold, 

and delivered, and that there was a 

variance in the HMC’s controlled 

substance inventory, are SUSTAINED, 

and weigh in favor of revoking the 

Respondent’s COR. 

The Respondent did not provide the 

DEA with a biennial inventory. Tr. 329, 

521. However, the Respondent provided 

the DEA with separate annual 

inventories for methadone diskettes and 

liquid methadone, as well as for 2 mg 

and 8 mg buprenorphine. GE–10, at 1– 

4; Tr. 368–70, 584. Notably, the 

regulations require a registrant to 


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67The Respondent also provided evidence that it 

created a monthly inventory generated from the 

daily dosing records. Tr. 114–15, 129. However, the 

record evidence indicates that this inventory did 

not involve an actual physical count of the 

Respondent’s controlled substances on hand. See 

Tr. 114–15, 129. For an inventory to satisfy the 

requirements of 21 C.F.R. 1304.11, the inventory 

must record a count of ‘‘all controlled substances 

on hand on the date the inventory is taken.’’ 21 

C.F.R. 1304.11(a). The monthly ‘‘inventories’’ do 

not satisfy this requirement and are properly 

considered to be monthly summaries of the 

dispensing logs, rather than actual inventories 

under the regulations. 

68The Case Agent’s chart contains errors. For 

example, it reports that the DEA did not receive the 

222 Form dated June 24, 2014, concerning liquid 

methadone and bearing DEA Order form number 

134110205. GE–16. The DEA, however, obtained 

that form during its inspection on October 14, 2014, 

while at the HMC. GE–13, at 3. Other errors are also 

present on the Case Agent’s document. She reports 

that DEA Order form numbers 130355192, 

130355182, 130355184, and 134110205 were not 

provided by the HMC. GE–16. That information is 

wrong. See GE–14, at 4–7. See also RE–BB, at 24– 

27, for comparison. 

69See Superior Pharmacy, 81 Fed. Reg. at 31338; 

Hills Pharmacy, 81 Fed. Reg. at 49842–43. The 

Government’s exhibits do not contain information 

even from the supplier regarding whether the 

substances purchased through the (allegedly 

incomplete) September 9, 2014 222 Form were 

shipped. Government’s Exhibit 15 includes a ship 

date of September 12, 2014, but the items shipped 

do not match those listed on the HMC’s September 

9, 2014 222 Form. Compare GE–13, at 1, with GE– 

15. 

inventory its controlled substances ‘‘at 

least every two years.’’ 21 C.F.R. 

1304.11(c) (emphasis added). If a 

registrant counts its controlled 

substances every day and records that 

count in a manner that satisfies the 

Code of Federal Regulations’ biennial 

inventory requirements, that daily 

inventory is considered to be an 

adequate biennial inventory. Tr. 246. 

Further, there is consistent credible 

testimony in the record that the 

dispensing nurses conducted a daily 

inventory of the controlled substances at 

the HMC. See Finding of Fact 4. Thus, 

the annual inventory provided to the 

DEA investigators would have been a 

sufficient inventory. The Government 

did not allege that the HMC’s inventory 

was inadequate; the Government only 

alleged that the HMC failed to conduct 

a biennial inventory. The HMC 

presented an inventory to the DEA 

investigators, and testimony supports 

that actual inventories were frequently 

conducted; therefore, the Government’s 

allegation that the Respondent failed to 

conduct a biennial inventory is NOT 

SUSTAINED.67

The Government also alleged that the 

HMC failed to conduct an inventory of 

buprenorphine. The HMC did not 

produce an initial inventory for 

buprenorphine. Tr. 456. Rather, the Case 

Agent saw McSwain attempting to 

create a buprenorphine inventory, at 

Mrs. Ozumba’s direction, during the 

2014 inspection to present to the DEA 

investigators. Tr. 92–94, 326. The Case 

Agent told McSwain to print off what 

she had without editing anything 

further. Tr. 326. These print-outs are 

pages three and four of GE–10. The 

Code of Federal Regulations, however, 

requires that an inventory of a 

controlled substance be taken on the 

date that a registrant ‘‘first engages in 

the . . . dispensing of controlled 

substances.’’ 21 C.F.R. 1304.11(b). 

Comparing the timeframes reflected on 

pages three and four of GE–10 with the 

timeframes reflected on page one of RE– 

E, and the dates reflected in RE–AA, 

and considering McSwain’s and the 

Case Agent’s testimonies, I find that the 

buprenorphine ‘‘inventory’’ presented to 

the DEA investigators during the 

inspection was not made during an 

actual physical count of the HMC’s 

controlled substances and, therefore, 

was not an inventory under 21 C.F.R. 

1304.11(b). Therefore, the Government’s 

allegation that the Respondent failed to 

conduct an inventory of buprenorphine 

is SUSTAINED, and weighs in favor of 

revoking the Respondent’s COR. 

In the fourth allegation, the 

Government charged that the HMC 

failed ‘‘to preserve DEA 222 Order 

Forms.’’ ALJ–1, at 3. In support of that 

allegation, the Government cited to 21 

C.F.R. 1305.17(a). Id. Nowhere prior to 

the hearing did the Government allege 

that the HMC failed to make its 222 

Forms readily available for inspection. 

The HMC provided some 222 Forms 

from the 2014 audit period in response 

to the request of the DEA investigators. 

GE–13, at 1–4; Tr. 354–55; see also Tr. 

89, 132–33, 1043. In conducting her 

audit, the Case Agent prepared a list of 

222 Forms she had received from the 

HMC with a list of 222 Forms she 

obtained from the HMC’s supplier. GE– 

16. On that list, the items in bold 

supposedly were not provided by the 

HMC to the DEA.68 While the HMC 

provided additional 222 Forms to DEA 

after the date of the inspection, the DEA 

did not include them in its audit of the 

HMC because they were received after 

the completion of the audit. Tr. 354, 

366–67. Nevertheless, there is one form 

that the Government identified, DEA 

Order form number 134110207, dated 

August 1, 2014, which the HMC has not 

produced. GE–16. Therefore, the 

Government’s allegation to that effect is 

SUSTAINED, and weighs in favor of 

revoking the Respondent’s COR. 

The record also establishes that the 

HMC submitted an incomplete 222 

Form, dated September 9, 2014, that 

failed to indicate the number of 

packages received or the date of receipt. 

GE–13, at 1; Tr. 354–55. However, the 

Government failed to submit evidence 

that the HMC actually received the 

ordered controlled substances and 

thereby failed to make a notation on the 

222 Form.69 Therefore, the 

Government’s allegation to that effect is 

NOT SUSTAINED. 

The Respondent also submitted a 

December 3, 2013 222 Form that bore 

Dr. Ozumba’s signature, instead of Mrs. 

Ozumba’s. GE–13, at 2; Tr. 355. The 

regulations permit only DEA registrants 

to issue orders for Schedule I and II 

controlled substances, unless a power of 

attorney authorizing another person to 

do so has been properly executed. 21 

C.F.R. 1305.04(a), 1305.05(a). The power 

of attorney must be issued by the DEA 

registrant. 21 C.F.R. 1305.05(a). The 

power of attorney must be retained with 

executed 222 Forms. Id. When Dr. 

Ozumba signed the 222 Form, Mrs. 

Ozumba was the DEA registrant for the 

HMC. Tr. 327. The DEA requested the 

HMC’s power of attorney forms. Tr. 96, 

1043. While McSwain knew that a 

power of attorney form had been 

prepared, she could not find it. Tr. 96. 

Ultimately, however, Dr. Ozumba 

provided the Case Agent with two 

power of attorney forms. Tr. 327–29, 

389–92. The first form was a blank 

power of attorney that was prepared for 

Dr. Orette’s signature, but Dr. Orette was 

not authorized to sign a power of 

attorney on behalf of the HMC because 

he was not the HMC’s DEA registrant. 

GE–21; Tr. 390, 598–99. The second 

form was a new power of attorney 

signed on the day of the inspection, 

which was purportedly signed without 

any witnesses, with ‘‘C. Ozumba’’ 

written in as the grantor, no name 

written in as the ‘‘attorney-in-fact,’’ and 

McSwain’s name signed as the ‘‘person 

granting power.’’ GE–20; Tr. 97, 328–29, 

395–96. Even if this form had been 

properly executed, it did not authorize 

Dr. Ozumba to sign 222 Forms for Mrs. 

Ozumba, who was the registrant for the 

HMC. Therefore, the Government’s 

allegation that the Respondent failed to 

execute a power of attorney to authorize 

an alternate person to sign 222 Forms is 

SUSTAINED, and weighs in favor of 

revoking the Respondent’s COR. 

Finally, the Government alleged that 

the HMC failed to completely and 

accurately complete daily dispensing 

logs for the controlled substances it 

dispensed. The record demonstrates that 

upon request, the HMC provided DEA 

with dispensing logs from October 1, 

2013 through October 14, 2014 for 

methadone diskettes, and dispensing 


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logs from September 30, 2013 through 

October 31, 2014 for liquid methadone. 

Tr. 105, 107, 135, 422, 456–57, 607, 

847–48, 849–50, 915, 1043–44; see RE– 

A–B. Using the same rationale that I 

applied to a similar allegation regarding 

the 2011 inspection, I find that the 

Government has not met its burden of 

proof with respect to the dispensing 

records contained in RE–A–B. 

Therefore, the Government’s allegation 

that the Respondent failed to completely 

and accurately complete daily 

dispensing logs for methadone diskettes 

and liquid methadone is NOT 

SUSTAINED. 

With respect to the dispensing logs for 

buprenorphine, the HMC did not 

provide any during the inspection. In 

support of that allegation, the 

Government cited to 21 C.F.R. 

1304.24(a). ALJ–1, at 3. Nowhere prior 

to the hearing did the Government 

allege that the HMC failed to make 

dispensing records readily available for 

inspection. At the hearing, the HMC 

provided for the first time the 

dispensing logs for buprenorphine. RE– 

AA; Tr. 461–62, 538. I find that those 

logs comply with the requirements of 21 

C.F.R. 1304.24(a). I further find that the 

HMC was not on notice that it would 

have to respond to a charge of failing to 

have its buprenorphine dispensing logs 

readily available for inspection. CBS 

Wholesale Distribs., 74 Fed. Reg. 36746, 

36749 (2009) (‘‘One of the fundamental 

tenets of Due Process is that Agency 

must provide a Respondent with notice 

of those acts which the Agency intends 

to rely on in seeking the revocation of 

its registration . . . .’’ (citations 

omitted)). Therefore, the Government’s 

allegation that the Respondent failed to 

completely and accurately complete 

daily dispensing logs for buprenorphine 

is NOT SUSTAINED. 

III. Notice of Misconduct 

The Government alleged that the 

HMC was given several chances to 

comply with DEA registration 

requirements. First, the DEA issued a 

Letter of Admonition to the HMC on 

May 1, 1997, detailing the deficiencies 

noted during the April 1997 inspection. 

Second, the DEA and Mrs. Ozumba 

entered into an MOU on March 13, 

2000, wherein she acknowledged the 

HMC’s violations from the December 6, 

1999 inspection, and she agreed to 

comply with DEA requirements. Third, 

the DEA issued a Letter of Admonition 

to the HMC on September 26, 2006, 

based on the September 8 and 11, 2006 

inspection. Fourth and finally, the HMC 

agreed to pay a $10,000 penalty on April 

3, 2013, to settle the DEA’s civil claims 

about violations discovered during the 

October 11 and 13, 2011 inspection, 

even though the Respondent denied 

culpability. 

Past behavior is the best predictor of 

future behavior. ALRA Labs., Inc. v. 

DEA, 54 F.3d 450, 452 (7th Cir. 1995). 

A narcotic treatment program’s history 

of violations is relevant when evaluating 

whether revocation is appropriate. 

Queens County, 50 Fed. Reg. at 2099. 

For example, in Berger, the Agency 

revoked a narcotic treatment program’s 

registration because the program had 

ample notice of its recordkeeping 

violations and controlled substance 

variances and, yet, continued to be 

noncompliant. 52 Fed. Reg. at 17645– 

46. In that case, the DEA, over the 

course of eleven years, notified the 

registrant of its recordkeeping 

violations, discussed the violations with 

it, and gave it time to correct the 

violations. Id. The DEA found that the 

registrant ‘‘consistently failed to 

maintain complete and accurate 

records,’’ even though it had ‘‘been 

given every opportunity by DEA to 

comply with the regulations.’’ Id. at 

17645. 

Here, the record shows that the HMC 

has had several opportunities to 

conform its behavior and recordkeeping 

to federal regulatory requirements and 

has consistently failed. Time and time 

again, the HMC was notified of its 

failings, but has yet to demonstrate that 

it can be a responsible registrant. While 

the Government has not proven each 

and every allegation set forth in the 

OSC, it need not do so. Rather, the law 

merely requires the Government to 

establish a noncompliance on the part of 

the Respondent with the standards 

respecting physical security and 

maintenance of records set forth by the 

Attorney General. As discussed supra, it 

has done so. Therefore, the 

preponderant evidence weighs in favor 

of the sanction sought by the 

Government. 

IV. The Respondent’s Defenses 

The Respondent argued in its 

prehearing statement that its significant 

and longstanding service to the 

community should be considered in 

evaluating whether its continued 

registration is appropriate. ALJ–6, at 3– 

4, 5; ALJ–14, at 5; Tr. 24–25. This 

argument fails for two reasons. First, the 

Respondent declined to present any 

community impact evidence at the 

hearing. Second, even if the Respondent 

had presented such evidence, 

community impact evidence is generally 

considered to be irrelevant to DEA 

revocation proceedings. See, e.g., Linda 

Sue Cheek, M.D., 76 Fed. Reg. 66972, 

66973 (2011) (noting that the DEA is not 

required to ‘‘consider community 

impact evidence’’); Bienvenido Tan, 

M.D., 76 Fed. Reg. 17673, 17694 n.58 

(2011); see also Holiday CVS, L.L.C., 77 

Fed. Reg. 62316, 62339 (2012) (‘‘Normal 

hardships to the practitioner and even 

to the surrounding community . . . are 

not relevant considerations.’’ (citations 

omitted)); Mark De La Lama, P.A., 76 

Fed. Reg. 20011, 20020 n.20 (2011) 

(declining to consider a registrant’s 

service to underserved and 

underinsured persons); Steven M. 

Abbadessa, D.O., 74 Fed. Reg. 10077, 

10078 (2009) (declining to consider the 

hardship imposed by the lack of a DEA 

registration). 

The Respondent also argued that the 

amount of time that has passed since 

some of its violations mitigates its 

misconduct. ALJ–14, at 11–12. In most 

DEA cases, the mere amount of time that 

has passed since a Respondent’s 

misconduct is not a relevant 

consideration in weighing the public 

interest factors. See, e.g., Tyson D. Quy, 

M.D., 78 Fed. Reg. 47412, 47418 (2013); 

Leonardo V. Lopez, M.D., 54 Fed. Reg. 

36915, 36916 (1989); see also Robert G. 

Hallermeier, M.D., 62 Fed. Reg. 26818, 

26821 (1997); John Porter Richards, 

D.O., 61 Fed. Reg. 13878, 13879 (1996); 

Norman Alpert, M.D., 58 Fed. Reg. 

67420, 67421 (1993). However, narcotic 

treatment programs are evaluated under 

21 U.S.C. § 823(g), which does not 

include a consideration of public 

interest factors, as discussed supra. 

A narcotic treatment program’s 

registration may be revoked based on 

any violation of any standard referred to 

in 21 U.S.C. § 823(g)(1). 21 U.S.C. 

§ 824(a). Factors are not weighed, and 

conduct is not mitigated; the plain 

language of the Controlled Substances 

Act allows for revocation based on a 

single violation. Here, the Government 

has shown far more than one violation 

of federal regulations. 

Although this is not a case in which 

public interest factors are weighed, it is 

a case wherein the Government seeks 

the revocation of a registrant’s COR. 

Therefore, it is appropriate to apply 

standard considerations to that 

question. In that regard, once the 

Government presents a prima facie case 

for revocation, the burden of production 

shifts to the registrant to present 

‘‘sufficient mitigating evidence’’ to show 

why it can be entrusted with a 

registration. 21 U.S.C. § 823(g)(1)(B) 

(connecting registration with a 

determination that there will be 

compliance with security and records 

maintenance requirements); see Med. 

Shoppe—Jonesborough, 73 Fed. Reg. at 

387 (quoting Samuel S. Jackson, D.D.S., 

72 Fed. Reg. 23848, 23853 (2007)). To 


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rebut the Government’s prima facie 

case, a registrant must both accept 

responsibility for its actions and 

demonstrate that it will not engage in 

future misconduct. Patrick W. Stodola, 

M.D., 74 Fed. Reg. 20727, 20734 (2009). 

The registrant may show acceptance of 

responsibility by providing evidence of 

remorse, efforts at rehabilitation, and 

recognition of the severity of its 

misconduct. Robert A. Leslie, M.D., 68 

Fed. Reg. 15227, 15228 (2003). 

The registrant must accept 

responsibility and take remedial 

measures for each separate act of 

misconduct that it committed. The 

Lawsons, Inc., 72 Fed. Reg. 74334, 

74339 (2007); see Jeffrey Patrick 

Gunderson, M.D., 61 Fed. Reg. 26208, 

26211 (1996) (noting that a registrant 

must demonstrate remorse to the full 

extent of the documented misconduct). 

Acceptance of responsibility and 

remedial measures are assessed in the 

context of the ‘‘egregiousness of the 

violations and the [DEA’s] interest in 

deterring similar misconduct by [the] 

Respondent in the future as well as on 

the part of others.’’ David A. Ruben, 

M.D., 78 Fed. Reg. 38363, 38364 (2013) 

(citation omitted). Here, the HMC must 

have accepted responsibility and taken 

adequate remedial measures regarding 

its recordkeeping and security 

violations. 

In this case, Mrs. Ozumba has only 

taken responsibility for the allegations 

surrounding the 1997 inspection, and 

for being absent from the HMC during 

the 2014 inspection. Tr. 685, 687, 693, 

929, 934. Applying the adage of ‘‘actions 

speak louder than words,’’ it would 

appear that the HMC has also accepted 

responsibility for the security violations 

that were identified in the 2011 

inspection. Those security concerns 

were addressed within a week of the 

inspection, and the HMC was not cited 

for any security violations in the 2014 

inspection. Tr. 290–91, 533, 739–40, 

901. Were the security issues the only 

matter pending before me, I would find 

that the HMC had presented sufficient 

mitigating evidence to show why it 

could be entrusted with a registration. 

Mrs. Ozumba testified that with 

respect to the 1999 and 2006 

inspections, she considered the matters 

resolved based upon her responses to 

the DEA shortly after those inspections. 

Tr. 697–98, 690–92, 694. She also sent 

letters to the DEA after these inspections 

indicating steps she had taken to ensure 

further compliance with federal 

regulations. See GE–27, 37. In addition, 

in both the 2000 MOU and the 2013 

Stipulated Agreement, the HMC agreed 

to comply with federal regulations 

governing the handling of controlled 

substances. See GE–7, 32. 

Unfortunately, there is no other 

evidence in the administrative record 

that supports a conclusion that the 

HMC’s prior violations were resolved, 

and the record does not support a 

conclusion that the terms of the MOU or 

the Stipulated Agreement have had any 

significant effect on the manner in 

which the HMC has maintained its 

records. 

Of note, Mrs. Ozumba indicated that 

she had conducted training after the 

2006 inspection, yet Bultron did not 

recall the HMC implementing any new 

policies, procedures or training after the 

2006 inspection. GE–27; Tr. 239–40, 

638. Mrs. Ozumba also testified that she 

had created a new form after the 2006 

inspection, but her office manager, 

Garnett, testified that he created the 

form in 2012. Tr. 931–35, 964–77; see 

also RE–X. In fact, there has been little 

change in the HMC’s recordkeeping 

from 1997 through 2014. See Findings 

of Fact 1–5, 42. Furthermore, where a 

registrant has not accepted 

responsibility for its actions, remedial 

measures are not relevant. See Hoxie v. 

DEA, 419 F.3d 477, 483 (6th Cir. 2005) 

(recognizing the importance of 

admitting fault). As discussed supra, the 

HMC has not accepted responsibility for 

its regulatory violations; therefore, any 

evidence of remedial measures is 

inconsequential. Therefore, the 

Respondent has failed to rebut the 

Government’s prima facie case. 

RECOMMENDATION 

‘‘One of the requirements for 

registration of a narcotic treatment 

program is that the program, comply 

with standards established by the 

Attorney General respecting . . . the 

maintenance of records (in accordance 

with section 827 of this title) on such 

drugs.’’ Berger, 52 Fed. Reg. at 17646 

(internal quotation marks omitted). 

‘‘The Administrator will not hesitate to 

revoke the registration of a n[a]rcotic 

treatment program that fails to meet its 

statutory and regulatory obligations to 

provide adequate security and 

recordkeeping.’’ Queens County, 50 Fed. 

Reg. at 2100. 

The HMC has had a relatively long 

history of violating the Controlled 

Substances Act and its implementing 

regulations. More specifically, over the 

course of seventeen years and five 

inspections, the HMC has consistently 

failed to keep complete and accurate 

records concerning the receipt, 

accounting, and dispensing of narcotic 

substances and on one occasion was 

found to have inadequate security for its 

controlled substances. Even more 

troubling is the fact that, as discussed 

supra, the HMC has been warned on 

several occasions of its recordkeeping 

failings and has been provided multiple 

opportunities to correct them. Despite 

those efforts for compliance, the HMC 

has consistently failed. 

‘‘Diversion, and the potential 

diversion of methadone from narcotic 

treatment programs, is of grave concern 

to the Administrator. . . . The DEA 

regulation and supervision of these 

programs is intended to prevent the loss 

and diversion of methadone.’’ Queens 

County, 50 Fed. Reg. at 2099–2100. A 

respondent who ‘‘manifests a casual 

indifference to its obligation to provide 

adequate security, to keep complete and 

accurate records, and to properly 

account for its supply of narcotic drugs’’ 

is unfit to handle narcotic substances. 

Id. at 2100. 

The record, as a whole, reveals a 

casual indifference on the part of the 

HMC to maintain adequate security and 

to keep complete and accurate records 

of its narcotic drug receipts, accounts, 

and dispensings. It also reflects that the 

HMC’s past failures are likely to 

continue. ‘‘The integrity of the 

controlled substances distribution 

system, particularly where highly 

abusable, dangerous, and much soughtafter drugs such as methadone are 

concerned, is too important a 

consideration to be left to speculation.’’ 

Metro Substance Abatement Program, 

Inc., 45 Fed. Reg. 78845, 78848 (1980). 

‘‘To hope that the Respondent will 

operate responsibly in the future, in 

light of its well-documented past 

performance, would be speculative at 

best.’’ Id. The HMC’s consistent 

noncompliance with federal law despite 

having been afforded every opportunity 

to comply demonstrates that it cannot 

be entrusted with a registration. ‘‘The 

public should not be placed at the risk 

of . . . diversion any longer.’’ Queens 

County, 50 Fed. Reg. at 2100. 

Therefore, I RECOMMEND that the 

Respondent’s DEA Certificate of 

Registration be REVOKED and any 

applications for renewal or modification 

of its registration be DENIED. 

Dated: September 30, 2016. 

Charles Wm. Dorman, 

Administrative Law Judge. 

[FR Doc. 2018–17889 Filed 8–17–18; 8:45 am] 

BILLING CODE 4410–09–P 


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