Jose Concepcion: Debarment Order, 20641-20642 [2012-8249]
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Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices
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.
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
Tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:20 Apr 04, 2012
Jkt 226001
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
20641
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
E:\FR\FM\05APN1.SGM
05APN1
20642
Federal Register / Vol. 77, No. 66 / Thursday, April 5, 2012 / Notices
Tkelley on DSK3SPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
16:20 Apr 04, 2012
Jkt 226001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 21, 2012, from 8 a.m. to 6
p.m.
Location: Hilton Washington DC
North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel telephone number is
301–977–8900.
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Contact Person: Avena Russell, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002,
Avena.Russell@fda.hhs.gov, 301–796–
3805, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), and follow the prompts to the
desired center or product area. Please
call the Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On June 21, 2012, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application, sponsored by
Dune Medical Devices, Inc., for the
MarginProbe System, that utilizes
electromagnetic waves to characterize
human tissue in real time and provides
intraoperative information on the
malignancy of the surface of the ex vivo
lumpectomy specimen.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 11, 2012. Oral
presentations from the public will be
scheduled between approximately
1 p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 77, Number 66 (Thursday, April 5, 2012)]
[Notices]
[Pages 20641-20642]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8249]
-----------------------------------------------------------------------
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 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
