[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20641-20642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8249]


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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.

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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 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 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

[[Page 20642]]

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. 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 conduct that served as a 
basis for the conviction undermines the process for the regulation of 
drugs. The proposal also offered Mr. Concepcion 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. Concepcion 
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 Jose Concepcion has been convicted of a felony under Federal law 
for conduct relating to the regulation of a drug product under the FD&C 
Act, and that the type of conduct that served as a basis for the 
conviction undermines the process for the regulation of drugs.
    As a result of the foregoing finding, Mr. Concepcion 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 section 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. Concepcion, in any capacity during 
Mr. Concepcion'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. 
Concepcion 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. Concepcion during his period of debarment (section 
306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Concepcion 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-2009-N-0331 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. 2012-8249 Filed 4-4-12; 8:45 am]
BILLING CODE 4160-01-P