FDA Debarment List (Drug Product Applications)
FDA Debarment List (Drug Product Applications)
Below is a public list of firms or persons currently debarred pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)) as published in the FEDERAL REGISTER (http://www.gpoaccess.gov/fr/) (FR). A listing of persons previously debarred can be found at this link.
Firms
| Name of Firm | Effective Date | End/Term of Debarment | FR Date.txt (MM/DD/YY) | Volume Page.pdf |
|---|---|---|---|---|
| None as of this date |
|
Persons
| Last Name | First & Middle Names | Effective Date | End/Term of Debarment | FR Date.txt (MM/DD/YY) | Volume Page.pdf |
|---|---|---|---|---|---|
| Acosta | Gina | 05/15/2024 | Permanent^ | 05/15/2024 | 89 FR 42474 |
| Akhigbe | Ehigiator O. | 12/17/2010 | 25 Year% | 12/17/2010 | 75 FR 79005 |
| Albanese | Anthony W. | 11/23/2009 | Permanent^ | 11/23/2009 | 74 FR 61151 |
| Aminzada | Mirwaiss | 06/22/2015 | Permanent^ | 06/22/2015 | 80 FR 35652 |
| Anthony | James Michael | 11/07/1997 | Permanent^ | 11/07/1997 | 62 FR 60249 |
| Anzures-Camarena | Maria | 05/29/2024 | Permanent^ | 05/29/2024 | 89 FR 46404 |
| Anwar | Sami | 02/02/2023 | Permanent^ | 02/02/2023 | 88 FR 7093 |
| Azeem | Mohammed | 04/26/1993 | Permanent^ | 04/26/1993 | 58 FR 21982~ |
| FR Correction | 05/05/1993 | 58 FR 26814~ | |||
| Babich | Michael L. | 11/27/2020 | Permanent^ | 11/27/2020 | 85 FR 76084 |
| Bae | Kun Chae | 12/30/1993 | Permanent^* | 12/30/1993 | 58 FR 69368~ |
| Banks | Norma D. | 08/28/1997 | Permanent^ | 08/28/1997 | 62 FR 45667 |
| Baxter | Timothy | 02/27/2023 | 5 Years% | 02/27/2023 | 88 FR 12369 |
| 02/29/2024 | Sp.Termination (10/26/2025) | 02/29/2024 | 89 FR 14861 | ||
| Bhutani | Baldev Raj | 12/02/2004 | Permanent^ | 12/02/2004 | 69 FR 70148 |
| Brown | Raymond Sean | 02/17/2017 | Permanent^ | 02/17/2017 | 82 FR 11044 |
| Burklakoff | Alec | 01/04/2021 | Permanent^ | 01/04/2021 | 86 FR 102 |
| Bushlow | John W. | 03/22/1996 | Permanent^* | 03/22/1996 | 61 FR 11846 |
| Butkovitz | Anne L. | 10/17/2006 | Permanent^ | 10/17/2006 | 71 FR 61061 |
| Cadden | Barry J. | 11/30/2020 | Permanent^ | 11/30/2020 | 85 FR 76582 |
| Campbell | Maria Anne Kirkman | 09/02/2008 | Permanent ^ | 09/02/2008 | 73 FR 51305 |
| Chang | Charles Y. | 03/08/1993 | Permanent^ | 03/08/1993 | 58 FR 12967~ |
| FR Correction | 04/26/1993 | 58 FR 21983~ | |||
| Colton | Steven F. | 06/17/1993 | Permanent^* | 06/17/1993 | 58 FR 33446~ |
| Copanos | John D. | 03/11/1996 | Permanent^* | 03/11/1996 | 61 FR 09711 |
| FR Correction | 04/18/1996 | 61 FR 16975 | |||
| Coroniti | Lisa Marie | 08/20/2015 | Permanent^ | 08/20/2015 | 80 FR 50636 |
| Courtney | Robert Ray | 10/20/2003 | Permanent^ | 10/20/2003 | 68 FR 59942 |
Daffin
| Diana | 07/27/2023 | Permanent^ | 07/27/2023 | 88 FR 48473 |
| Delong | Karis Copper | 2/17/2017 | 12 years % | 2/17/2017 | 82 FR 11045 |
| Desai | Kanubhai C. | 10/06/1993 | Permanent^ | 10/06/1993 | 58 FR 52111~ |
| Diaz | Daylen | 06/21/2023 | Permanent^ | 06/21/2023 | 88 FR 40275 |
| Dicola | Charles G. | 11/05/1993 | Permanent^* | 11/05/1993 | 58 FR 59044~ |
| **Donnelly | Mary | 11/29/1993 | Permanent^ | 11/29/1993 | 58 FR 62675~ |
| Durr | Patricia | 07/09/2015 | Permanent^ | 07/09/2015 | 80 FR 39439 |
| Edwards | Brenda E. | 03/19/2020 | Permanent^ | 03/19/2020 | 85 FR 15791 |
| Edwards | Charles J. | 03/18/2020 | Permanent^ | 03/18/2020 | 85 FR 15481 |
| Elbert | Robert | 04/03/1997 | Permanent^* | 04/03/1997 | 62 FR 15902 |
| Elmer | Paul J. | 07/24/2020 | Permanent^ | 07/24/2020 | 85 FR 44899 |
| Elsharaiha | Rami | 09/29/2000 | Permanent^ | 09/29/2000 | 65 FR 58555 |
| Figueroa | Raidel | 08/03/2023 | Permanent^ | 08/03/2023 | 88 FR 51328 |
| Fleming | Richard M. | 9/28/2018 | 10 years % | 9/28/2018 | 83 FR 49095 |
| Finelli | Gena R. | 04/21/1993 | Permanent^ | 04/21/1993 | 58 FR 21469~ |
| Fogari | Robert A. | 07/08/1993 | Permanent^* | 07/08/1993 | 58 FR 36691~ |
| Garfinkel | Barry D. | 04/02/1997 | Permanent^* | 04/02/1997 | 162 FR 1573 |
| Girdhari | Premchand | 01/21/2000 | Permanent^* | 01/21/2000 | 65 FR 03454 |
| Giron | Angela Maria | 05/02/2024 | Permanent^* | 05/02/2024 | 89 FR 35836 |
| Gonsalves, Jr. | Wallace | 10/21/2009 | Permanent^ | 10/21/2009 | 74 FR 54051 |
| Gurry | Michael | 03/21/2021 | Permanent^ | 03/21/2021 | 86 FR 12473 |
| Hendrick | Kim C. | 08/04/2009 | Permanent^ | 08/04/2009 | 74 FR 38656 |
| Herman | Hedviga | 10/17/1997 | Permanent^ | 10/17/1997 | 62 FR 54117 |
| Hossain | Liaquat | 11/05/1993 | Permanent^* | 11/05/1993 | 58 FR 59046~ |
| Huda | Syed | 09/16/2015 | Permanent^ | 09/16/2015 | 80 FR 55632 |
| Justice | Glen R. | 07/09/2012 | 25 years % | 07/09/2012 | 77 FR 40366 |
| Kalinoski | Stephen | 03/19/2020 | Permanent^ | 03/19/2020 | 85 FR 15792 |
| Kane | Niaja | 11/23/2009 | Permanent^ | 11/23/2009 | 74 FR 61150 |
| Kapoor | John | 11/30/2020 | Permanent^ | 11/30/2020 | 85 FR 76581 |
| Khan | Talib | 07/08/2015 | Permanent^ | 07/08/2015 | 80 FR 39121 |
| Kimball | James T. | 01/30/2007 | Permanent ^ | 01/30/2007 | 72 FR 4269 |
| Kincaid | William Ralph | 1/18/2018 | Permanent ^ | 1/18/2018 | 83 FR 2641 |
| Kindness | George J. | 11/24/2008 | Permanent ^ | 11/24/2008 | 73 FR 71007 |
| Kletch | Walter S. | 11/29/1994 | Permanent^* | 11/29/1994 | 59 FR 60989~ |
| Kokes | Edwin | 04/30/2003 | Permanent^ | 04/30/2003 | 68 FR 23138 |
| Kornak | Paul H. | 08/04/2009 | Permanent^ | 08/04/2009 | 74 FR 38657 |
| Kostas | Constantine I. | 06/25/1998 | Permanent^* | 06/10/1998 | 63 FR 34652 |
| Laing | Euton | 07/24/2020 | Permanent^ | 07/24/2020 | 85 FR 44898 |
| Lais | Patrick J. | 2/23/2010 | Permanent^ | 2/23/2010 | 75 FR 8081 |
| Lee | Sunrise | 01/04/2021 | Permanent^ | 01/04/2021 | 86 FR 100 |
| Lentini | Jerome | 05/09/2012 | Permanent^* | 05/09/2012 | 77 FR 27235 |
| Letizia, Jr. | Gabriel | 01/18/2023 | Permanent^ | 01/18/2023 | 88 FR 2935 |
| Liang | Cheng Yi | 03/06/2013 | Permanent^ | 03/06/2013 | 78 FR 14556 |
| Lledo | Maytee | 11/23/2021 | Permanent^ | 11/23/2021 | 86 FR 66566 |
| Long | Susan M. | 12/23/1993 | Permanent^* | 12/23/1993 | 58 FR 68147~ |
| Mannan | Muhammad Z. | 04/06/1993 | Permanent^ | 04/06/1993 | 58 FR 17896~ |
| Manookian, a.k.a. Ed Manning | Edward | 11/14/2016 | Permanent^ | 11/14/2016 | 81 FR 79501 |
| Marks | Stephen L. | 02/22/2012 | Permanent^ | 02/22/2012 | 77 FR 10533 |
| Martinez-Seldon | Deborah | 10/5/2011 | Permanent^ | 10/5/2011 | 76 FR 61712 |
| Massouh | Marwan | 05/11/2022 | 3 years % | 05/11/2022 | 87 FR 28834 |
| McQuerry | Wesley A. | 3/18/2016 | Permanent^ | 3/18/2016 | 81 FR 14862 |
| Mendell | Arnold S. | 12/21/1994 | Permanent^* | 12/21/1994 | 59 FR 65773 |
| Montalvo Villa | Miguel Angel | 11/20/2024 | Permanent^ | 11/20/2024 | 89 FR 91758 |
| Morris | Andrew | 05/16/1994 | Permanent^# | 01/11/1995 | 60 FR 02767 |
| Nathan | Ray | 8/9/2011 | Permanent^ | 8/09/2011 | 76 FR 48869 |
| Navarro | Eduardo | 03/03/2022 | Permanent^ | 03/03/2022 | 87 FR 12171 |
| Ngo | Belen G. | 08/02/2021 | 5 years%* | 08/02/2021 | 86 FR 41486 |
| Page | Roy C. | 11/24/2008 | Permanent ^ | 11/24/2008 | 73 FR 71008 |
| Pai, a.k.a. Lau, Daphne | Daphne | 11/05/1993 | Permanent^* | 11/05/1993 | 58 FR 59048~ |
| Palacio | Jessica | 05/28/2024 | Permanent^ | 05/28/2024 | 89 FR 46125 |
| Palaparty | Poornanand | 01/25/2023 | 3 years% | 01/25/2023 | 88 FR 4830 |
| Palazzo | Maria Carmen | 4/6/2011 | Permanent^ | 4/6/2011 | 76 FR 19100 |
| ***Patel | Ashok | 11/08/1994 | Permanent^* | 11/08/1994 | 59 FR 55670~ |
| Patel | Kalpen D. | 02/14/2024 | Permanent^ | 02/14/2024 | 89 FR 11296 |
| Petrik | Craig H. | 04/30/2002 | Permanent^ | 04/30/2002 | 67 FR 21255 |
| Peugeot | Renee | 01/13/2003 | Permanent^ | 01/13/2003 | 68 FR 1619 |
| Poet | Albert | 03/03/2011 | Permanent^ | 03/03/2011 | 76 FR 11789 |
| Portela Martinez | Ivette Maria | 11/19/2024 | Permanent^ | 11/19/2024 | 89 FR 91406 |
| Prasad | Kumar | 06/30/1993 | Permanent^ | 06/30/1993 | 58 FR 35006~ |
| Quamruzzaman | Abu | 11/18/1993 | Permanent^# | 12/30/1994 | 59 FR 67709~ |
| Rana | Nandlal | 10/20/1997 | Permanent^ | 10/20/1997 | 62 FR 54462 |
| Raventos | Lisett | 04/14/2022 | Permanent^ | 04/14/2022 | 87 FR 22218 |
| Reed | Willis | 03/21/2024 | Permanent^ | 03/21/2024 | 89 FR 20205 |
| Reuben | Scott S. | 11/16/2011 | Permanent^ | 11/16/2011 | 76 FR 71042 |
| Reinhard | Mark | 04/14/2021 | Permanent^ | 04/14/2021 | 86 FR 19625 |
| Rico | Analay | 06/08/2023 | Permanent^ | 06/08/2023 | 88 FR 37546 |
| Rivers | Jacob H. | 04/12/1993 | Permanent^ | 04/12/1993 | 58 FR 19128~ |
| Rodriguez | Juan Manuel | 07/26/1993 | Permanent^ | 07/26/1993 | 58 FR 39819~ |
| Rothenberg | Gayle | 11/8/2011 | Permanent^ | 11/8/2011 | 76 FR 69272 |
| Rowan | Joseph A. | 01/04/2021 | Permanent^ | 01/04/2021 | 86 FR 103 |
| Runsdorf | Adam Paul | 05/07/2024 | Permanent^ | 05/07/2024 | 89 FR 38159 |
| Ryan | Patrick T. | 11/29/1994 | Permanent^ | 11/29/1994 | 59 FR 60992~ |
| FR Correction | 01/17/1995 | 60 FR 03451 | |||
| Ryan | Lawrence B. | 03/21/2021 | Permanent^ | 03/21/2021 | 86 FR 12482 |
| Sacher | Robert E. | 08/11/1997 | Permanent^ | 08/11/1997 | 62 FR 42998 |
| Santos | Armando | 11/10/2014 | 12 years % | 11/10/2014 | 79 FR 66728 |
| Sardesai | Suhas V. | 09/30/2003 | Permanent^ | 09/30/2003 | 68 FR 56299 |
| Sarraf | Anoushirvan | 06/22/2015 | Permanent^ | 06/22/2015 | 80 FR 35653 |
| Sawaya, a.k.a. Marty Sawaya | Mary E. | 06/12/2009 | Permanent^ | 06/12/2009 | 74 FR 28049 |
| Schetlick | Gloria H. | 04/26/1993 | Permanent^ | 04/26/1993 | 58 FR2 1983~ |
| Schroeder | Matthew | 10/26/2017 | Permanent^ | 10/26/2017 | 82 FR 49634 |
| Seldon | Stephen Lee | 5/27/2011 | Permanent^ | 5/27/2011 | 76FR30947 |
| Settino | Gregory | 10/18/2022 | Permanent^* | 10/18/2022 | 87 FR 63076 |
| Shah | Dilip | 08/31/1993 | Permanent^* | 08/31/1993 | 58 FR 45899~ |
| Shah | Satish R. | 08/01/1994 | Permanent^* | 08/01/1994 | 59 FR 38983~ |
| Shainfeld | Frederick Jay | 03/10/1995 | Permanent^# | 02/28/1996 | 61 FR 07521 |
| Sharp | Lisa Jean | 08/23/2012 | Permanent^ | 08/23/2012 | 77 FR 56647 |
| Shaver | Jonathan R. | 06/13/2024 | Permanent^ | 06/13/2024 | 89 FR 50343 |
| Shrum | Kelly Dean | 08/23/2012 | Permanent^ | 08/23/2012 | 77 FR 51030 |
| ****Shulman | Robert | 08/27/1993 | Permanent^ | 08/27/1993 | 58 FR 45340~ |
| Simon | Richard M. | 11/19/2020 | Permanent^ | 11/192020 | 85 FR 73726 |
| Singh | Paul S. | 11/15/2016 | Permanent^ | 11/15/2016 | 81 FR 80073 |
| Smith | Jerrod Nichols | 01/04/2021 | Permanent^ | 01/04/2021 | 86 FR 101 |
| Smith | Louis Daniel | 11/15/2016 | Permanent^ | 11/15/2016 | 81 FR 80077 |
| Snyder, Jr. | Harry W. | 01/13/2003 | Permanent^ | 01/13/2003 | 68 FR 1619 |
| Spencer | Wayne E. | 09/13/2012 | Permanent^ | 09/13/2012 | 77 FR 56646 |
| Striefsky | Edmund J. | 09/30/2003 | Permanent^ | 09/30/2003 | 68 FR 56300 |
| Sturm | Jan T. | 06/22/1993 | Permanent^ | 06/22/1993 | 58 FR 33941~ |
| FR Correction | 07/06/1993 | 58 FR 36252~ | |||
| Tahsildar | Hassan | 02/08/2023 | 2 years% | 02/08/2023 | 88 FR 8292 |
| Tatsene | Mayya | 09/12/2023 | Permanent^ | 09/12/2023 | 88 FR 62575 |
| Tejeda | Duniel | 08/02/2022 | Permanent^ | 08/02/2022 | 87 FR 47218 |
| Thaxter | Shaun | 02/27/2023 | 5 years% | 02/27/2023 | 88 FR 12375 |
| Theodore | Thomas Ronald | 08/05/2003 | Permanent^ | 08/05/2003 | 68 FR 46197 |
| Tighe | Gerald | 03/19/2020 | Permanent^ | 03/19/2020 | 85 FR 15790 |
| Torgerson | Michelle Lynn | 11/13/2009 | Permanent^ | 11/13/2009 | 74 FR 58639 |
| Torres | Olga L. | 04/12/2023 | Permanent^ | 04/12/2023 | 88 FR 22043 |
| Uddin | Mohammad | 09/29/2000 | Permanent^ | 09/29/2000 | 65 FR 58557 |
| Ullom | Brian | 2/2/2010 | Permanent^ | 2/2/2010 | 75 FR 5332 |
| Valdes | Martin | 3/25/2024 | Permanent^ | 3/25/2024 | 89 FR 20664 |
| Vale | Jason | 1/12/2010 | Permanent^ | 1/12/2010 | 75 FR 1623 |
| Van Wormer | Mark E. | 3/10/2011 | Permanent^ | 3/10/2011 | 76 FR 13192 |
| Varona | Nayade | 03/15/2022 | Permanent^ | 03/15/2022 | 87 FR 14539 |
| Vegesna | Raju | 04/12/1993 | Permanent^ | 04/12/1993 | 58 FR 19129~ |
| Wells | Ivyl W. | 4/19/2011 | Permanent^ | 4/19/2011 | 76 FR 21910 |
| Villaman-Bencosme | Yvelice | 4/19/2022 | Permanent^ | 4/19/2022 | 87 FR 23184 |
| Xu | Kevin | 4/8/2010 | Permanent^ | 4/8/2010 | 75 FR 17927 |
| Yoser | Seth M. | 5/20/2010 | Permanent^ | 8/18/2010 | 75 FR 51079 |
NOTATIONS:
^ Mandatory Debarment (Sec. 306(a))
% Permissive Debarment (Sec. 306(b))
* Hearing requested and denied.
# Acquiesced to Debarment.
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
** Ms Mary L. Donnelly, of Green Bay City, Michigan, USA (FDA Docket No. 93N-0264), is not to be confused with Dr. Mary Sandra Donnelly, currently affiliated with St. Michael's Hospital of Toronto, Ontario, Canada.
***Ashok Patel of Upper Saddle River, New Jersey, USA (FDA Docket No. 92N-0417), is not to be confused with Dr. Ashokkumar Bhailaibhai Patel (a.k.a. Ashok B. Patel), currently affiliated with Radiant Research, St. Louis, Missouri nor with Ashok Shankarbhai Patel of Allegan, MI, currently affiliated with Perrigo Company.
**** Robert Shulman, of Centerport, NY, USA (FDA Docket No. 93N-0069), is not to be confused with Dr. Robert J. Shulman, currently affiliated with Baylor College of Medicine, Children's Nutrition Research Center, Texas Children's Hospital.
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.
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.