Inspections, Compliance, Enforcement, and Criminal Investigations
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FDA Debarment List (Drug Product Applications)
The following is a public list of firms or persons debarred pursuant to sections 306(a), (b)(1) and (b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a), (b)(1), and (b)(2)) as published in the FEDERAL REGISTER (FR):
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
| NAME OF PERSON | 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 | 76FR30946 |
| Akhigbe, Ehigiator O. | 12/17/2010 | 25 Year% | 12/17/2010 | 75FR79005 |
| Albanese, Anthony W. | 11/23/2009 | Permanent^ | 11/23/2009 | 74FR61151 |
| Anthony, James Michael | 11/07/1997 | Permanent^ | 62FR60249 | |
| Azeem, Mohammed | 04/26/1993 | Permanent^ | 04/26/1993 | 58FR21982 |
| FR Correction | 05/05/1993 | 58FR26814 | ||
| Bae, Kun Chae | 12/30/1993 | Permanent^* | 12/30/1993 | 58FR69368 |
| Banks, Norma D. | 08/28/1997 | Permanent^ | 62FR45667 | |
| Bansal, Padam C. | 11/29/1993 | Permanent^* | 11/29/1993 | 58FR62674 |
| Berman, David E. | 3/9/2011 | 3 Years% | 3/9/2011 | 76FR12971 |
| 03/11/1997 | Sp.Trmnation+ | 62FR11212 | ||
| Bhutani, Baldev Raj | 12/02/2004 | Permanent^ | 69FR70148 | |
| Borison, Richard L. | 09/30/2003 | 10 years% | 68FR56298 | |
| Brancato, David J. | 01/06/1994 | Permanent^* | 59FR00751 | |
| Bushlow, John W. | 03/22/1996 | Permanent^* | 61FR11846 | |
| Butkovitz, Anne L. | 10/17/2006 | Permanent^ | 71FR61061 | |
| Campbell, Maria Anne Kirkman | 09/02/2008 | Permanent ^ | 73FR51305 | |
| Caro Acevedo, Eduardo | 03/24/2005 | 5 years% | 70FR15107 | |
| Chang, Charles Y. | 03/08/1993 | Permanent^ | 03/08/1993 | 58FR12967 |
| FR Correction | 04/26/1993 | 58FR21983 | ||
| Charpentier, Laverne M. | 12/02/2002 | 5 years%* | 67FR71574 | |
| Chatman, Cathryn Lyn a.k.a. Cathryn Lyn Garcia | 4/7/2011 | 5 years% | 4/7/2011 | 76FR19373 |
| Chatterji, Dulal C. | 11/01/1995 | Permanent^# | 62FR03297 | |
| Choi, Andrew K. | 8/08/2011 | 4 years% | 8/08/2011 | 76FR48168 |
| 06/11/1998 | Sp.Trmnation+ | 63FR32013 | ||
| Cioffi, Albert Ronald | 10/25/2011 | 5 years% | 10/25/2011 | 76FR66072 |
| Colton, Steven F. | 06/17/1993 | Permanent^* | 06/17/1993 | 58FR33446 |
| Concepcion, Jose | 04/05/2012 | 5 years % | 04/05/2012 | 77FR20641 |
| Copanos, John D. | 03/11/1996 | Permanent^* | 61FR09711 | |
| FR Correction | 61FR16975 | |||
| Courtney, Robert Ray | 10/20/2003 | Permanent^ | 68FR59942 | |
| Desai, Kanubhai C. | 10/06/1993 | Permanent^ | 10/06/1993 | 58FR52111 |
| Dicola, Charles G. | 11/05/1993 | Permanent^* | 11/05/1993 | 58FR59044 |
| **Donnelly, Mary | 11/29/1993 | Permanent^ | 11/29/1993 | 58FR62675 |
| Elbert, Robert | 04/03/1997 | Permanent^* | 62FR15902 | |
| Elsharaiha, Rami | 09/29/2000 | Permanent^ | 65FR58555 | |
| Feuer, Scott | 06/02/1998 | 5 years% | 63FR31789 | |
| Fiddes, Robert A. | 11/06/2002 | 20 years% | 67FR67628 | |
| 01/21/2003 | FR Correction | 58FR2784 | ||
| Finelli, Gena R. | 04/21/1993 | Permanent^ | 04/21/1993 | 58FR21469 |
| Fogari, Robert A. | 07/08/1993 | Permanent^* | 07/08/1993 | 58FR36691 |
| Garfinkel, Barry D. | 04/02/1997 | Permanent^* | 162FR1573 | |
| Girdhari, Premchand | 01/21/2000 | Permanent^* | 65FR03454 | |
| Gonsalves, Jr., Wallace | 10/21/2009 | Permanent^ | 10/21/2009 | 74FR54051 |
| Hendrick, Kim C. | 08/04/2009 | Permanent^ | 08/04/2009 | 74FR38656 |
| Herman, Hedviga | 10/17/1997 | Permanent^ | 62FR54117 | |
| Holland, James A. | 3/4/2010 | 5 years%* | 3/4/2010 | 75FR9904 |
| Hossain, Liaquat | 11/05/1993 | Permanent^* | 11/05/1993 | 58FR59046 |
| Islam, Amirul | 08/27/1997 | Permanent^# | 62FR45423 | |
| 10/09/2003 | Sp. Trmnation+ | 68FR58352 | ||
| Justice, Glen R. | 07/09/2012 | 25 years % | 07/09/2012 | 77FR40366 |
| Kalidindi, Sanyasi Raju | 04/21/1993 | Permanent^ | 04/21/1993 | 58FR21470 |
| Kane, Niaja | 11/23/2009 | Permanent^ | 11/23/2009 | 74FR61150 |
| Kimball, James T. | 01/30/2007 | Permanent ^ | 01/30/2007 | 72FR4269 |
| Kindness, George J. | 11/24/2008 | Permanent ^ | 73FR71007 | |
| Kletch, Walter S. | 11/29/1994 | Permanent^* | 59FR60989 | |
| Knott, Susan F. | 12/11/2012 | 2 years % | 12/11/2012 | 77FR73663 |
| Kokes, Edwin | 04/30/2003 | Permanent^ | 68FR23138 | |
| Kornak, Paul H. | 08/04/2009 | Permanent^ | 08/04/2009 | 74FR38657 |
| Kostas, Constantine I. | 06/25/1998 | Permanent^* | 63FR34652 | |
| Lai, Elaine Yee-Ling | 11/13/2002 | 5 years% | 67FR68877 | |
| FR Correction | 68FR03264 | |||
| Lais, Patrick J. | 2/23/2010 | Permanent^ | 2/23/2010 | 75FR8081 |
| Lentini, Jerome | 05/09/2012 | Permanent^* | 05/09/2012 | 77FR27235 |
| Long, Susan M. | 12/23/1993 | Permanent^* | 12/23/1993 | 58FR68147 |
| Macwan, Ashish | 04/05/2012 | 5 years % | 04/05/2012 | 77FR20638 |
| Mannan, Muhammad Z. | 04/06/1993 | Permanent^ | 04/06/1993 | 58FR17896 |
| Marcus, Jay | 09/29/2000 | 5 years% | 65FR58556 | |
| Marks, Stephen L. | 02/22/2012 | Permanent^ | 02/22/2012 | 77FR10533 |
| Matkari, Rajaram K. | 10/20/1993 | Permanent^* | 10/20/1993 | 58FR54156 |
| 06/13/2000 | Withdrawn++ | 65FR37154 | ||
| Mays, Gary D. | 01/24/1997 | 5 years% | 62FR03703 | |
| Mehlmauer, Marilyn A. | 4/4/2011 | 4 years% | 4/4/2011 | 76FR18557 |
| Mendell, Arnold S. | 12/21/1994 | Permanent^* | 59FR65773 | |
| Morris, Andrew | 05/16/1994 | Permanent^# | 60FR02767 | |
| Nathan, Ray | 8/9/2011 | Permanent^ | 8/09/2011 | 76FR48869 |
| Norman, Allyn M. | 06/12/2009 | 5 years% | 06/12/2009 | 74FR28050 |
| One person removed from list | 11/06/2002 | Rescission!!! | 68FR2339 | |
| Page, Roy C. | 11/24/2008 | Permanent ^ | 73FR71008 | |
| Pai, Daphne (aka Lau, Daphne) | 11/05/1993 | Permanent^* | 11/05/1993 | 58FR59048 |
| Palazzo, Maria Carmen | 4/6/2011 | Permanent^ | 4/6/2011 | 76FR19100 |
| Panagotacos, Daphne I. | 05/09/2012 | 5 Years %* | 05/09/2012 | 77FR27236 |
| Pappas, Anastasios | 3/9/2011 | 5 Years% | 3/9/2011 | 76FR12971 |
| ***Patel, Ashok | 11/08/1994 | Permanent^* | 59FR55670 | |
| Parikh, Jyotin | 04/06/2012 | 5 years % | 04/06/2012 | 77FR20823 |
| Perkal, Mark B. | 11/29/1993 | Permanent^ | 11/29/1993 | 58FR62676 |
| 09/11/1998 | Sp.Trmnation+ | 63FR48733 | ||
| Petrik, Craig H. | 04/30/2002 | Permanent^ | 67FR21255 | |
| Peugeot, Renee | 01/13/2003 | Permanent^ | 68FR1619 | |
| Poet, Albert | 03/03/2011 | Permanent^ | 03/03/2011 | 76FR11789 |
| Prasad, Kumar | 06/30/1993 | Permanent^ | 06/30/1993 | 58FR35006 |
| Quamruzzaman, Abu | 11/18/1993 | Permanent^# | 59FR67709 | |
| Rana, Nandlal | 10/20/1997 | Permanent^ | 62FR54462 | |
| Reuben, Scott S. | 11/16/2011 | Permanent^ | 11/16/2011 | 76FR71042 |
| Rivers, Jacob H. | 04/12/1993 | Permanent^ | 04/12/1993 | 58FR19128 |
| Rodgers, Jr., Thomas M. | 07/28/2005 | 5 years% | 71FR43699 | |
| Rodriguez, Juan Manuel | 07/26/1993 | Permanent^ | 07/26/1993 | 58FR39819 |
| Rosio, Timothy J. | 6/24/2011 | 4 years% | 6/24/2011 | 76FR37126 |
| Rothenberg, Gayle | 11/8/2011 | Permanent^ | 11/8/2011 | 76FR69272 |
| Ruetschi, Maja S. | 4/4/2011 | 5 Years% | 4/4/2011 | 76FR18556 |
| Ryan, Patrick T. | 11/29/1994 | Permanent^ | 59FR60992 | |
| FR Correction | 60FR03451 | |||
| Sacher, Robert E. | 08/11/1997 | Permanent^ | 62FR42998 | |
| Sardesai, Suhas V. | 09/30/2003 | Permanent^ | 68FR56299 | |
| Sawaya, Mary E. a.k.a. Marty Sawaya | 06/12/2009 | Permanent^ | 06/12/2009 | 74FR28049 |
| Schetlick, Gloria H. | 04/26/1993 | Permanent^ | 04/26/1993 | 58FR21983 |
| Martinez-Seldon, Deborah | 10/5/2011 | Permanent^ | 10/5/2011 | 76FR61712 |
| Seldon, Stephen Lee | 5/27/2011 | Permanent^ | 5/27/2011 | 76FR30947 |
| Shah, Atul | 12/05/1994 | Permanent^* | 59FR62399 | |
| 03/11/1997 | Sp.Trmnation+ | 62FR11212 | ||
| Shah, Dilip | 08/31/1993 | Permanent^* | 08/31/1993 | 58FR45899 |
| Shah, Satish R. | 08/01/1994 | Permanent^* | 59FR38983 | |
| Shah, Shashikant | 04/05/2012 | 5 years % | 04/05/2012 | 77FR20639 |
| Shainfeld, Frederick Jay | 03/10/1995 | Permanent^# | 61FR07521 | |
| Sharp, Lisa Jean | 08/23/2012 | Permanent^ | 08/23/2012 | 77FR56647 |
| ****Shulman, Robert NMI | 08/27/1993 | Permanent^ | 08/27/1993 | 58FR45340 |
| Shrum, Kelly Dean | 08/23/2012 | Permanent^ | 08/23/2012 | 77FR51030 |
| Snyder, Jr., Harry W. | 01/13/2003 | Permanent^ | 68FR1619 | |
| Spencer, Wayne E. | 09/13/2012 | Permanent^ | 77FR56646 | |
| Striefsky, Edmund J. | 09/30/2003 | Permanent^ | 68FR56300 | |
| Sturm, Jan T. | 06/22/1993 | Permanent^ | 06/22/1993 | 58FR33941 |
| FR Correction | 07/06/1993 | 58FR36252 | ||
| Theodore, Thomas Ronald | 08/05/2003 | Permanent^ | 68FR46197 | |
| Torgerson, Michelle Lynn | 11/13/2009 | Permanent^ | 11/13/2009 | 74FR58639 |
| Uddin, Mohammad NMI | 09/29/2000 | Permanent^ | 65FR58557 | |
| Ullom, Brian | 2/2/2010 | Permanent^ | 2/2/2010 | 75FR5332 |
| Vale, Jason | 1/12/2010 | Permanent^ | 1/12/2010 | 75FR1623 |
| Van Wormer, Mark, E. | 3/10/2011 | Permanent^ | 3/10/2011 | 76FR13192 |
| Vegesna, Raju | 04/12/1993 | Permanent^ | 04/12/1993 | 58FR19129 |
| Wells, Ivyl W. | 4/19/2011 | Permanent^ | 4/19/2011 | 76FR21910 |
| Xu, Kevin | 4/8/2010 | Permanent^ | 4/8/2010 | 75FR17927 |
| Yanikian, Sami Arshak | 07/02/2012 | 10 years % | 07/02/2012 | 77FR39245 |
| Yoser, Seth M. | 5/20/2010 | Permanent^ | 8/18/2010 | 75FR51079 |
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 |
| aka | Also known as |
| NMI | No Middle Initial known to be used |
| ** | 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 |
| **** | 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. For access to debarment proceedings which have been initiated, click on the link on the left hand side 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 the Office of Enforcement, Division of Compliance Policy (HFC-230), 5600 Fishers Lane, Rockville, Maryland 20857; telephone 240.632.6860; FAX 240.632.6861. 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) Background information on Debarment: ["FDA Consumer" magazine March 1997 "Inside FDA:Barring People from the Drug Industry"] Hyperlinks to FEDERAL REGISTER statements are provided where available. Debarments prior to 1994 are not available online. |
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