Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 20639 

served as the basis for the conviction 

undermines the process for the 

regulation of drugs. 

On November 30, 2010, judgment was 

entered against Mr. Macwan in the 

United District Court for the District of 

New Jersey based upon a plea of guilty 

to one count of conspiracy to commit an 

offense against the United States, in 

violation of 18 U.S.C. 371. 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for the conviction is as 

follows: Mr. Macwan was employed at 

Able Laboratories, Inc. (Able) as a 

chemist in Able’s Quality Control 

Department from in or around mid-1999 

through May 2003. In or around January 

2005, Mr. Macwan was promoted to 

Assistant Manager in the Quality 

Control Department and was 

responsible for supervising numerous 

chemists, monitoring the chemists’ 

compliance with current Good 

Manufacturing Practices, as required by 

the FD&C Act and FDA regulations. 

Able developed, manufactured, and sold 

several generic drug products, including 

products for cardiac and psychiatric 

conditions and prescription pain 

relievers. 

From in or around 1999 through on or 

about May 19, 2005, Mr. Macwan 

conspired to cause the introduction and 

delivery for introduction into interstate 

commerce of a drug that was adulterated 

and misbranded, with an intent to 

defraud and mislead, contrary to 18 

U.S.C. 371, 21 U.S.C. 331(a), and 

333(a)(2). 

Mr. Macwan and his coconspirators 

impaired, impeded, defeated, and 

obstructed FDA’s lawful government 

function to approve the manufacture 

and distribution of generic drug 

products by violating Good 

Manufacturing Practices; violating 

Standards of Procedure by failing to 

properly investigate, log, and archive 

questionable, aberrant, and 

unacceptable laboratory results so that 

Able could conceal improprieties and 

continue to distribute and sell its drug 

products; manipulating and falsifying 

testing data and information to conceal 

from FDA failing laboratory results 

relating to Able’s generic drug products; 

creating and maintaining false, 

fraudulent, and inaccurate test results to 

make it appear that drug products had 

the requisite identity, strength, quality, 

and purity characteristics so the drug 

products could be distributed and sold 

to increase Able’s sales and profit; and 

creating and maintaining false, 

fraudulent, and inaccurate data and 

records to obtain FDA approval to 

market new product lines. 

In furtherance of the conspiracy, in or 

around September 2003, Mr. Macwan 

falsified and manipulated testing data 

relating to the finished product testing 

for acetaminophen with codeine 

phosphate, a prescription pain relieving 

drug product. In addition, in or around 

September 2003, Mr. Macwan and his 

coconspirators falsified and 

manipulated testing data relating to the 

finished product testing for 

phentermine hydrochloride, a 

prescription drug developed to treat 

obesity. 

As a result of his conviction, on 

December 20, 2011, FDA sent Mr. 

Macwan a notice by certified mail 

proposing to debar him for 5 years from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. The proposal 

was based on a finding, under section 

306(b)(2)(B)(i)(II) of the FD&C Act, that 

Mr. Macwan was convicted of a 

conspiracy under Federal law for 

conduct relating to the development and 

approval, including the process for 

development and approval of a drug 

product, and to the regulation of drug 

products under the FD&C Act, and the 

conduct that served as a basis for the 

conviction undermined the process for 

the regulation of drugs. The proposal 

also offered Mr. Macwan an opportunity 

to request a hearing, providing him 30 

days from the date of receipt of the letter 

in which to file the request, and advised 

him that failure to request a hearing 

constituted a waiver of the opportunity 

for a hearing and of any contentions 

concerning this action. Mr. Macwan 

failed to request a hearing within the 

timeframe prescribed by regulation and, 

therefore, has waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment 

(21 CFR Part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under section 306(b)(2)(B)(i)(II) 

of the FD&C Act, under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Ashish Macwan has 

been convicted of a conspiracy under 

Federal law for conduct relating to the 

development and approval, including 

the process for development and 

approval of a drug product, and to the 

regulation of drug products under the 

FD&C Act, and that the type of conduct 

that served as a basis for the conviction 

undermined the process for the 

regulation of drugs. 

As a result of the foregoing finding, 

Mr. Macwan is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under sections 

505, 512, or 802 of the FD&C Act (21 

U.S.C. 355, 360b, or 382), or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262), effective (see 

DATES), (see sections 306(c)(1)(B), 

(c)(2)(A)(iii), and 201(dd) of the FD&C 

Act (21 U.S.C. 335a(c)(1)(B), 

(c)(2)(A)(iii), and 321(dd))). Any person 

with an approved or pending drug 

product application who knowingly 

employs or retains as a consultant or 

contractor, or otherwise uses the 

services of Mr. Macwan, in any capacity 

during Mr. Macwan’s debarment, will 

be subject to civil money penalties 

(section 307(a)(6) of the FD&C Act (21 

U.S.C. 335b(a)(6))). If Mr. Macwan 

provides services in any capacity to a 

person with an approved or pending 

drug product application during his 

period of debarment he will be subject 

to civil money penalties (section 

307(a)(7) of the FD&C Act). In addition, 

FDA will not accept or review any 

abbreviated new drug applications 

submitted by or with the assistance of 

Mr. Macwan during his period of 

debarment (section 306(c)(1)(B) of the 

FD&C Act). 

Any application by Mr. Macwan for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2009– 

N–0330 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: March 27, 2012. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2012–8233 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0659] 

Shashikant Shah: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Shashikant Shah for 5 years from 


Tkelley on DSK3SPTVN1PROD with NOTICES
20640 Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on a finding that Mr. Shah 

was convicted of one count of 

conspiracy to commit an offense against 

the United States for conduct relating to 

the development and approval, 

including the process for development 

and approval, of a drug product and to 

the regulation of drug products under 

the FD&C Act. In addition, the type of 

conduct underlying the conviction 

undermined the process for the 

regulation of drugs. Mr. Shah was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. Mr. Shah failed to request a 

hearing, which constitutes a waiver of 

his right to a hearing concerning this 

action. 

DATES: This order is effective April 5, 

2012. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs, Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., rm. 

4144, Rockville, MD 20857, 301–796– 

4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(II) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(II)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a conspiracy to commit a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product or 

relating to the regulation of any drug 

product under the FD&C Act, and if 

FDA finds that the type of conduct that 

served as the basis for the conviction 

undermines the process for the 

regulation of drugs. 

On December 17, 2010, judgment was 

entered against Mr. Shah in the U.S. 

District Court for the District of New 

Jersey based upon a plea of guilty to one 

count of conspiracy to commit an 

offense against the United States, in 

violation of 18 U.S.C. 371. 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for the conviction is as 

follows: Mr. Shah was employed at Able 

Laboratories, Inc. (Able) as vice 

president of quality assurance/quality 

control and regulatory affairs from in or 

around mid-1999 through in or around 

December 27, 2004. Able developed, 

manufactured, and sold several generic 

drug products, including products for 

cardiac and psychiatric conditions and 

prescription pain relievers. 

As Able’s vice president of quality 

control and regulatory affairs, Mr. Shah 

was responsible for supervising as many 

as 100 employees, including numerous 

managers and supervisors, and several 

laboratory chemists. Mr. Shah’s other 

responsibilities included supervising 

the quality control and testing processes 

of the drug products manufactured and 

sold by Able, ensuring compliance with 

current Good Manufacturing Practices, 

as required by the FD&C Act and FDA 

regulations. 

From in or around 1999 through on or 

about May 19, 2005, Mr. Shah conspired 

to cause the introduction and delivery 

for introduction into interstate 

commerce of a drug that was adulterated 

and misbranded, with an intent to 

defraud and mislead, contrary to 18 

U.S.C. 371 and 21 U.S.C. 331(a) and 

333(a)(2). 

Mr. Shah and his co-conspirators 

impaired, impeded, defeated, and 

obstructed FDA’s lawful government 

function to approve the manufacture 

and distribution of generic drug 

products by violating Good 

Manufacturing Practices; violating 

standards of procedure by failing to 

properly investigate, log, and archive 

questionable, aberrant, and 

unacceptable laboratory results so that 

Able could conceal improprieties and 

continue to distribute and sell its drug 

products; manipulating and falsifying 

testing data and information to conceal 

from FDA failing laboratory results 

relating to Able’s generic drug products; 

creating and maintaining false, 

fraudulent, and inaccurate test results to 

make it appear that drug products had 

the requisite identity, strength, quality, 

and purity characteristics so the drug 

products could be distributed and sold 

to increase Able’s sales and profit; and 

creating and maintaining false, 

fraudulent, and inaccurate data and 

records to obtain FDA approval to 

market new product lines. 

In furtherance of the conspiracy, in or 

around 2002, Mr. Shah supervised the 

falsification of testing data for Able’s 

butalbital, acetaminophen, and caffeine 

products. In or around 2003, Mr. Shah 

supervised the falsification of testing 

data for Able’s methylphenidate 

product. Mr. Shah additionally directed 

and supervised the creation of false and 

fraudulent entries in chemist laboratory 

notebooks, and in the corresponding 

process validation binders, relating to 

Able’s abbreviated new drug application 

for lithium carbonate extended release 

tablets, for which Able received FDA 

approval on or about April 21, 2003. 

As a result of his conviction, on 

December 20, 2011, FDA sent Mr. Shah 

a notice by certified mail proposing to 

debar him for 5 years from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. The proposal was 

based on a finding, under section 

306(b)(2)(B)(i)(II) of the FD&C Act that 

Mr. Shah was convicted of a conspiracy 

under Federal law for conduct relating 

to the development and approval, 

including the process for development 

and approval of a drug product, and to 

the regulation of drug products under 

the FD&C Act, and the conduct that 

served as a basis for the conviction 

undermined the process for the 

regulation of drugs. The proposal also 

offered Mr. Shah an opportunity to 

request a hearing, providing him 30 

days from the date of receipt of the letter 

in which to file the request, and advised 

him that failure to request a hearing 

constituted a waiver of the opportunity 

for a hearing and of any contentions 

concerning this action. Mr. Shah failed 

to request a hearing within the 

timeframe prescribed by regulation and 

has, therefore, waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under Section 306(b)(2)(B)(i)(II) 

of the FD&C Act, under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Shashikant Shah 

has been convicted of a conspiracy 

under Federal law for conduct relating 

to the development and approval, 

including the process for development 

and approval of a drug product, and to 

the regulation of drug products under 

the FD&C Act, and that the type of 

conduct that served as a basis for the 

conviction undermined the process for 

the regulation of drugs. 

As a result of the foregoing finding, 

Mr. Shah is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under sections 

505, 512, or 802 of the FD& C Act (21 

U.S.C. 355, 360b, or 382), or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262), effective (see 

DATES), (see sections 306(c)(1)(B), 

(c)(2)(A)(iii), and 201(dd) of the FD&C 

Act (21 U.S.C. 335a(c)(1)(B), 

(c)(2)(A)(iii), and 321(dd))). Any person 


Tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices 20641 

with an approved or pending drug 

product application who knowingly 

employs or retains as a consultant or 

contractor, or otherwise uses the 

services of Mr. Shah, in any capacity 

during Mr. Shah’s debarment, will be 

subject to civil money penalties (section 

307(a)(6) of the FD&C Act (21 U.S.C. 

335b(a)(6))). If Mr. Shah provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment he will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act (21 U.S.C. 335b(a)(7))). In 

addition, FDA will not accept or review 

any abbreviated new drug applications 

submitted by or with the assistance of 

Mr. Shah during his period of 

debarment (section 306(c)(1)(B) of the 

FD&C Act). 

Any application by Mr. Shah for 

termination of debarment under section 

306(d)(1) of the FD&C Act (21 U.S.C. 

355a(d)(1)) should be identified with 

Docket No. FDA–2011–N–0659 and sent 

to the Division of Dockets Management 

(see ADDRESSES). All such submissions 

are to be filed in four copies. The public 

availability of information in these 

submissions is governed by 21 CFR 

10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: March 27, 2012. 

Armando Zamora, 

Acting Director, Office of Enforcement, Office 

of Regulatory Affairs. 

[FR Doc. 2012–8229 Filed 4–4–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0331] 

Jose Concepcion: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Jose Concepcion for 5 years from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on findings that Mr. 

Concepcion was convicted of 

conspiracy to commit an offense against 

the United States, that the conduct that 

served as the basis for the felony 

conspiracy conviction relates to the 

development or approval, including the 

process for development or approval, of 

any drug product and relates to the 

regulation of drug products under the 

FD&C Act, and that the type of conduct 

underlying the conviction undermines 

the process for the regulation of drugs. 

Mr. Concepcion was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. Mr. 

Concepcion failed to request a hearing. 

Mr. Concepcion’s failure to request a 

hearing constitutes a waiver of his right 

to a hearing concerning this action. 

DATES: This order is effective April 5, 

2012. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs, Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., rm. 

4144, Rockville, MD 20857, 301–796– 

4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(II) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(II)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a conspiracy to commit a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product or 

otherwise relating to the regulation of a 

drug product under the FD&C Act, if 

FDA finds that the type of conduct that 

served as the basis for the conviction 

undermines the process for the 

regulation of drugs. 

On December 1, 2010, based upon a 

plea of guilty to one count of conspiracy 

to commit an offense against the United 

States, in violation of 18 U.S.C. 371, 

judgment was entered against Mr. 

Concepcion in the U.S. District Court for 

the District of New Jersey. 

FDA’s finding that debarment is 

appropriate is based on the conspiracy 

conviction referenced herein. The 

factual basis for the conviction is as 

follows: Mr. Concepcion was employed 

at Able Laboratories, Inc. (Able) from 

mid-1998 until January 2005. Able 

developed, manufactured, and sold 

several generic drug products, including 

products for cardiac and psychiatric 

conditions and prescription pain 

relievers. Mr. Concepcion was 

employed as a chemist in the Quality 

Control Department performing 

analytical tests on Able products to 

ensure product safety and effectiveness 

from in or around mid-1998 to around 

January 2001. In or around January 

2001, Mr. Concepcion was promoted to 

group leader and around April 2002, he 

was promoted to supervisor in the 

Quality Control Department. 

As group leader and supervisor in the 

Quality Control Department, Mr. 

Concepcion’s responsibilities included 

supervising numerous chemists and 

technicians who performed analytical 

quality control tests on Able’s generic 

drug products to ensure product safety 

and effectiveness; monitoring the 

chemists’ compliance with current Good 

Manufacturing Practices, as required by 

the FD&C Act and FDA regulations; and 

ensuring compliance with Able’s 

standard operating procedures (SOPs). 

From in or around 1999 through 

January, 2005, Mr. Concepcion 

conspired to cause the introduction and 

delivery for introduction into interstate 

commerce of a drug that was adulterated 

and misbranded, with an intent to 

defraud and mislead, contrary to 18 

U.S.C. 371 and 21 U.S.C. 331(a) and 

333(a)(2). 

Mr. Concepcion and his coconspirators impaired, impeded, 

defeated, and obstructed FDA’s lawful 

government function to approve the 

manufacture and distribution of generic 

drug products by violating Good 

Manufacturing Practices; violating SOPs 

by failing to properly investigate, log, 

and archive questionable, aberrant, and 

unacceptable laboratory results so that 

Able could conceal improprieties and 

continue to distribute and sell its drug 

products; manipulating and falsifying 

testing data and information to conceal 

from FDA failing laboratory results 

relating to Able’s generic drug products; 

creating and maintaining false, 

fraudulent, and inaccurate test results to 

make it appear that drug products had 

the requisite identity, strength, quality, 

and purity characteristics so the drug 

products could be distributed and sold 

to increase Able’s sales and profit; and 

creating and maintaining false, 

fraudulent, and inaccurate data and 

records to obtain FDA approval to 

market new product lines. 

In furtherance of the conspiracy, in or 

around December 2001, Mr. Concepcion 

and his co-conspirators falsified and 

manipulated testing data relating to 

stability tests for propoxphene napsylate 

and acetaminophen. 

As a result of his conviction, on 

January 6, 2012, FDA sent Mr. 

Concepcion a notice by certified mail 

proposing to debar him for 5 years from 

providing services in any capacity to a 


Tkelley on DSK3SPTVN1PROD with NOTICES