FDA Expired Debarment List (Drug Product Applications)
FDA Expired Debarment List (Drug Product Applications)
Below is a public list of firms or persons whose debarment pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)) has either expired or has been terminated.
Firms
| Name of Firm | Effective Date | End/Term of Debarment | FR Date.txt (MM/DD/YY) | Volume Page.pdf |
|---|---|---|---|---|
| None at this time |
Persons
| Last Name | First & Middle Names | Effective Date | End/Term of Debarment | FR Date.txt (MM/DD/YY) | Volume Page.pdf |
|---|---|---|---|---|---|
| Last Name | First & Middle Names | Effective Date | End/Term of Debarment | FR Date.txt (MM/DD/YY) | Volume Page.pdf |
| Aiache | Adrien E. | 5/27/2011 | 5 years% | 5/27/2011 | 76 FR 30946 |
| Bansal | Padam C. | 11/29/1993 | Permanent^* | 11/29/1993 | 58 FR 62674~ |
| 03/11/1997 | Sp.Trmnation+ | 03/11/1997 | 62 FR 11212 | ||
| Berman | David E. | 3/9/2011 | 3 Years % | 3/9/2011 | 76 FR 12971 |
| Bhandari | Ranjan | 12/27/2018 | 3 years% | 12/27/2018 | 83 FR 66717 |
| Borison | Richard L. | 09/30/2003 | 10 years% | 09/30/2003 | 68 FR 56298 |
| Brancato | David J. | 01/06/1994 | Permanent^* | 01/06/1994 | 59FR00751 |
| 7/20/2015 | Sp.Termination+ | 6/22/2015 | 80 FR 42826 | ||
| Caro Acevedo | Eduardo | 03/24/2005 | 5 years% | 03/24/2005 | 70 FR 15107 |
| Charpentier | Laverne M. | 12/02/2002 | 5 years%* | 12/02/2002 | 67 FR 71574 |
| Chatman, a.k.a. Cathryn Lyn Garcia | Cathryn Lyn | 4/7/2011 | 5 years% | 4/7/2011 | 76 FR 19373 |
| Chatterji | Dulal C. | 11/01/1995 | Permanent^# | 01/22/1997 | 62 FR 03297 |
| 06/11/1998 | Sp.Trmnation+ | 06/11/1998 | 63 FR 32013 | ||
| Choi | Andrew K. | 8/08/2011 | 4 years% | 8/08/2011 | 76 FR 48168 |
| Cioffi | Albert Ronald | 10/25/2011 | 5 years% | 10/25/2011 | 76 FR 66072 |
| Concepcion | Jose | 04/05/2012 | 5 years % | 04/05/2012 | 77 FR 20641 |
| DeLuca, Jr. | William F. | 03/05/2015 | 5 years% | 03/05/2015 | 80 FR 12011 |
| Diamond | Bruce I. | 11/14/2013 | 10 years % | 11/14/2013 | 78 FR 68455 |
| Fernandez | Odalys | 3/31/2015 | 6 years% | 3/31/2015 | 80 FR 17049 |
| Feuer | Scott | 06/02/1998 | 5 years% | 06/10/1998 | 63 FR 31789 |
| Fiddes | Robert A. | 11/06/2002 | 20 years% | 11/06/2002 | 67 FR 67628 |
| 01/21/2003 | FR Correction | 01/21/2003 | 58 FR 2784 | ||
| Fishman | David J. | 12/11/2018 | 3 years% | 12/11/2018 | 83 FR 63657 |
| Foyle | Ashley Brandon | 05/01/2013 | 5 years% | 03/18/2013 | 78 FR 25456 |
| Freeman | David | 05/08/2013 | 5 years% | 05/08/2013 | 78 FR 26784 |
| Gil | Isachi | 10/17/2018 | 6 years % | 10/17/2018 | 83 FR 52487 |
| Hargrave | Douglas M. | 03/05/2015 | 2 years% | 03/05/2015 | 80 FR 11995 |
| Holland | James A. | 3/4/2010 | 5 years%* | 3/4/2010 | 75 FR 9904 |
| Islam | Amirul | 08/27/1997 | Permanent^# | 08/27/1997 | 62 FR 45423 |
| 10/09/2003 | Sp. Trmnation+ | 10/09/2003 | 68 FR 58352 | ||
| Kalidindi | Sanyasi Raju | 04/21/1993 | Permanent^ | 04/21/1993 | 58 FR 21470~ |
| 11/16/2021 | Sp. Trmnation+ | 11/16/2021 | 86 FR 63401 | ||
| Knott | Susan F. | 12/11/2012 | 2 years % | 12/11/2012 | 77 FR 73663 |
| Kuo | Su-Chiao | 12/11/2018 | 3 years% | 12/11/2018 | 83FR63656 |
| Lai | Elaine Yee-Ling | 11/13/2002 | 5 years% | 11/13/2002 | 67 FR 68877 |
| FR Correction | 11/23/2003 | 68 FR 03264 | |||
| Lynch | Steven M. | 03/05/2015 | 2 years% | 03/05/2015 | 80 FR 12013 |
| Macwan | Ashish | 04/05/2012 | 5 years % | 04/05/2012 | 77 FR 20638 |
| Marcus | Jay | 09/29/2000 | 5 years% | 09/29/2000 | 65 FR 58556 |
| Matkari | Rajaram K. | 10/20/1993 | Permanent^* | 10/20/1993 | 58 FR 54156~ |
| 06/13/2000 | Withdrawn++ | 06/13/2000 | 65 FR 37154 | ||
| Mays | Gary D. | 01/24/1997 | 5 years% | 01/24/1997 | 62 FR 03703 |
| McCoy | John D | 9/28/2018 | 4 years % | 9/28/2018 | 83 FR 49099 |
| Mehlmauer | Marilyn A. | 4/4/2011 | 4 years% | 4/4/2011 | 76 FR 18557 |
| Moffett | Mark | 01/25/2023 | Permanent^ | 01/25/2023 | 88 FR 4826 |
| 07/14/2023 | Withdrawn++ | 07/14/2023 | 88 FR 45228 | ||
| Nguyen | Trang Doan | 10/24/2017 | 5 years% | 10/24/2017 | 82 FR 49211 |
| Noonan | John D. | 03/05/2015 | 2 years% | 03/05/2015 | 80 FR 12007 |
| Norman | Allyn M. | 06/12/2009 | 5 years% | 06/12/2009 | 74 FR 28050 |
| One person removed from list | 11/06/2002 | Rescission!!! | 01/16/2003 | 68 FR 2339 | |
| Panagotacos | Daphne I. | 05/09/2012 | 5 Years %* | 05/09/2012 | 77 FR 27236 |
| Pappas | Anastasios | 3/9/2011 | 5 Years% | 3/9/2011 | 76 FR 12971 |
| Parikh | Jyotin | 04/06/2012 | 5 years % | 04/06/2012 | 77 FR 20823 |
| Patel | Dilip | 9/27/2018 | 5 years % | 9/27/2018 | 83 FR 48829 |
| Patel | Vithal K. | 08/02/2021 | 1 year % | 08/02/2021 | 86 FR 41483 |
| Perkal | Mark B. | 11/29/1993 | Permanent^ | 11/29/1993 | 58 FR 62676~ |
| 09/11/1998 | Sp.Trmnation+ | 09/11/1998 | 63 FR48733 | ||
| Pierce | Keith J. | 12/21/2017 | 5 Years % | 12/21/2017 | 82FD60611 |
| Rockmore | Jeffrey L. | 03/05/2015 | 2 years% | 03/05/2015 | 80 FR 11991 |
| Rodgers, Jr. | Thomas M. | 07/28/2005 | 5 years% | 07/28/2005 | 71 FR 43699 |
| Rosio | Timothy J. | 6/24/2011 | 4 years% | 6/24/2011 | 76FR37126 |
| Ruetschi | Maja S. | 4/4/2011 | 5 Years% | 4/4/2011 | 76 FR 18556 |
| Shah | Atul | 12/05/1994 | Permanent^* | 12/05/1994 | 59 FR 62399~ |
| 03/11/1997 | Sp.Trmnation+ | 03/11/1997 | 62 FR 11212 | ||
| Shah | Shashikant | 04/05/2012 | 5 years % | 04/05/2012 | 77 FR 20639 |
| Soto | Kelvin | 10/20/2014 | 6 years % | 10/20/2014 | 79 FR 62634 |
Winne | David | 08/18/2023 | Permanent^ | 08/18/2023 | 88 FR 56636 |
11/01/2023 | Sp.Termination (08/17/2024) | 11/01/2023 | |||
| Yanikian | Sami Arshak | 07/02/2012 | 10 years % | 07/02/2012 | 77 FR 39245 |
NOTATIONS:
^ Mandatory Debarment (Sec. 306(a))
% Permissive Debarment (Sec. 306(b))
* Hearing requested and denied.
# Acquiesced to Debarment.
+ Special Termination of Debarment (Sec. 306(d)(4)(C) and (d)(4)(D))
++ Order to Withdraw Order of Debarment (debarment terminated) (Sec. 306(d)(3)(B)(i))
!!! Rescission of Debarment Order
!!! Rescission of Debarment Order
aka Also known as
NMI No Middle Initial known to be used
~ Federal Register Documents dating before 1995 are available via PDF at govinfo.gov
This public list is compiled in accordance with 21 U.S.C. 335a(e) from notices published in the FEDERAL REGISTER. Firm or individual names appearing for the first time in a FR notice of debarment are added to the end of the list. Subsequent FR debarment notices concerning the same firm or person are posted after the first listing of the firm or individual.
For access to debarment proceedings which have been initiated, click on the link on of this page under "Resources For You." This will take you to a site containing NOOH letters (Notice of Opportunity for Hearing). The debarred candidates can be identified where the phrase (Proposal to Debar) is located under the candidates' name. Click on the individual's name to view the Proposal to Debar.
This list is prepared by ORA's Division of Enforcement: 12420 Parklawn Drive, Rockville, Maryland 20857; email: debarments@fda.hhs.gov.
Additional references:
- Clinical Investigators - Disqualification Proceedings
- The Public Health Service Administrative Actions Listing
- FEDERAL REGISTER (publications from 1994 to date)
- Debarment certification statements: Draft guidance for industry (PDF)
Please note: Hyperlinks to FEDERAL REGISTER statements are provided where available. Debarments prior to 1994 are not available online.