Inspections, Compliance, Enforcement, and Criminal Investigations

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 FIRMEFFECTIVE DATEEND/TERM OF DEBARMENTFR DATE.txt (MM/DD/YY)VOLUME PAGE.pdf
None as of this date   

Persons

NAME OF PERSONEFFECTIVE DATEEND/TERM OF DEBARMENTFR DATE.txt (MM/DD/YY)VOLUME PAGE.pdf
Aiache, Adrien E.5/27/20115 years%5/27/201176FR30946
Akhigbe, Ehigiator O.12/17/201025 Year%12/17/201075FR79005
Albanese, Anthony W.11/23/2009Permanent^11/23/200974FR61151
Anthony, James Michael11/07/1997Permanent^11/07/199762FR60249
Azeem, Mohammed04/26/1993Permanent^04/26/199358FR21982
  FR Correction05/05/199358FR26814
Bae, Kun Chae12/30/1993Permanent^*12/30/199358FR69368
Banks, Norma D.08/28/1997Permanent^08/28/199762FR45667
Bansal, Padam C.11/29/1993Permanent^*11/29/199358FR62674
 03/11/1997Sp.Trmnation+03/11/199762FR11212
Berman, David E.3/9/20113 Years%3/9/201176FR12971
Bhutani, Baldev Raj12/02/2004Permanent^12/02/200469FR70148
Borison, Richard L.09/30/200310 years%09/30/200368FR56298
Brancato, David J.01/06/1994Permanent^*01/06/199459FR00751
Bushlow, John W.03/22/1996Permanent^*03/22/199661FR11846
Butkovitz, Anne L.10/17/2006Permanent^10/17/200671FR61061
Campbell, Maria Anne Kirkman09/02/2008Permanent ^09/02/200873FR51305
Caro Acevedo, Eduardo03/24/20055 years%03/24/200570FR15107
Chang, Charles Y.03/08/1993Permanent^03/08/199358FR12967
  FR Correction04/26/199358FR21983
Charpentier, Laverne M.12/02/20025 years%*12/02/200267FR71574
Chatman, Cathryn Lyn a.k.a. Cathryn Lyn Garcia4/7/20115 years%4/7/201176FR19373
Chatterji, Dulal C.11/01/1995Permanent^#01/22/199762FR03297
 06/11/1998Sp.Trmnation+06/11/199863FR32013
Choi, Andrew K.8/08/20114 years%8/08/201176FR48168
Cioffi, Albert Ronald10/25/20115 years%10/25/201176FR66072
Colton, Steven F.06/17/1993Permanent^*06/17/199358FR33446
Concepcion, Jose04/05/20125 years %04/05/201277FR20641
Copanos, John D.03/11/1996Permanent^*03/11/199661FR09711
  FR Correction04/18/199661FR16975
Courtney, Robert Ray10/20/2003Permanent^10/20/200368FR59942
Desai, Kanubhai C.10/06/1993Permanent^10/06/199358FR52111
Diamond, Bruce I.11/14/201310 years %11/14/201378FR68455
Dicola, Charles G.11/05/1993Permanent^*11/05/199358FR59044
**Donnelly, Mary11/29/1993Permanent^11/29/199358FR62675
Elbert, Robert04/03/1997Permanent^*04/03/199762FR15902
Elsharaiha, Rami09/29/2000Permanent^09/29/200065FR58555
Feuer, Scott06/02/19985 years%06/10/199863FR31789
Fiddes, Robert A.11/06/200220 years%11/06/200267FR67628
 01/21/2003FR Correction01/21/200358FR2784
Finelli, Gena R.04/21/1993Permanent^04/21/199358FR21469
Fogari, Robert A.07/08/1993Permanent^*07/08/199358FR36691
Foyle, Ashley Brandon05/01/20135 years%03/18/201378FR25456
Freeman, David05/08/20135 years%05/08/201378FR26784
Garfinkel, Barry D.04/02/1997Permanent^*04/02/1997162FR1573
Girdhari, Premchand01/21/2000Permanent^*01/21/200065FR03454
Gonsalves, Jr., Wallace10/21/2009Permanent^10/21/200974FR54051
Hendrick, Kim C.08/04/2009Permanent^08/04/200974FR38656
Herman, Hedviga10/17/1997Permanent^10/17/199762FR54117
Holland, James A.3/4/20105 years%*3/4/201075FR9904
Hossain, Liaquat11/05/1993Permanent^*11/05/199358FR59046
Islam, Amirul08/27/1997Permanent^#08/27/199762FR45423
 10/09/2003Sp. Trmnation+10/09/200368FR58352
Justice, Glen R.07/09/201225 years %07/09/201277FR40366
Kalidindi, Sanyasi Raju04/21/1993Permanent^04/21/199358FR21470
Kane, Niaja11/23/2009Permanent^11/23/200974FR61150
Kimball, James T.01/30/2007Permanent ^01/30/200772FR4269
Kindness, George J.11/24/2008Permanent ^11/24/200873FR71007
Kletch, Walter S.11/29/1994Permanent^*11/29/199459FR60989
Knott, Susan F.12/11/20122 years %12/11/201277FR73663
Kokes, Edwin04/30/2003Permanent^04/30/200368FR23138
Kornak, Paul H.08/04/2009Permanent^08/04/200974FR38657
Kostas, Constantine I.06/25/1998Permanent^*06/10/199863FR34652
Lai, Elaine Yee-Ling11/13/20025 years%11/13/200267FR68877
  FR Correction11/23/200368FR03264
Lais, Patrick J.2/23/2010Permanent^2/23/201075FR8081
Lentini, Jerome05/09/2012Permanent^*05/09/201277FR27235
Liang, Cheng Yi03/06/2013Permanent^03/06/201378FR14556
Long, Susan M.12/23/1993Permanent^*12/23/199358FR68147
Macwan, Ashish04/05/20125 years %04/05/201277FR20638
Mannan, Muhammad Z.04/06/1993Permanent^04/06/199358FR17896
Marcus, Jay09/29/20005 years%09/29/200065FR58556
Marks, Stephen L.02/22/2012Permanent^02/22/201277FR10533
Matkari, Rajaram K.10/20/1993Permanent^*10/20/199358FR54156
 06/13/2000Withdrawn++06/13/200065FR37154
Mays, Gary D.01/24/19975 years%01/24/199762FR03703
Mehlmauer, Marilyn A.4/4/20114 years%4/4/201176FR18557
Mendell, Arnold S.12/21/1994Permanent^*12/21/199459FR65773
Morris, Andrew05/16/1994Permanent^#01/11/199560FR02767
Nathan, Ray8/9/2011Permanent^8/09/201176FR48869
Norman, Allyn M.06/12/20095 years%06/12/200974FR28050
One person removed from list11/06/2002Rescission!!!01/16/200368FR2339
Page, Roy C.11/24/2008Permanent ^11/24/200873FR71008
Pai, Daphne (aka Lau, Daphne)11/05/1993Permanent^*11/05/199358FR59048
Palazzo, Maria Carmen4/6/2011Permanent^4/6/201176FR19100
Panagotacos, Daphne I.05/09/20125 Years %*05/09/201277FR27236
Pappas, Anastasios3/9/20115 Years%3/9/201176FR12971
Parikh, Jyotin04/06/20125 years %04/06/201277FR20823
***Patel, Ashok11/08/1994Permanent^*11/08/199459FR55670
Perkal, Mark B.11/29/1993Permanent^11/29/199358FR62676
 09/11/1998Sp.Trmnation+09/11/199863FR48733
Petrik, Craig H.04/30/2002Permanent^04/30/200267FR21255
Peugeot, Renee01/13/2003Permanent^01/13/200368FR1619
Poet, Albert03/03/2011Permanent^03/03/201176FR11789
Prasad, Kumar06/30/1993Permanent^06/30/199358FR35006
Quamruzzaman, Abu11/18/1993Permanent^#12/30/199459FR67709
Rana, Nandlal10/20/1997Permanent^10/20/199762FR54462
Reuben, Scott S.11/16/2011Permanent^11/16/201176FR71042
Rivers, Jacob H.04/12/1993Permanent^04/12/199358FR19128
Rodgers, Jr., Thomas M.07/28/20055 years%07/28/200571FR43699
Rodriguez, Juan Manuel07/26/1993Permanent^07/26/199358FR39819
Rosio, Timothy J.6/24/20114 years%6/24/201176FR37126
Rothenberg, Gayle11/8/2011Permanent^11/8/201176FR69272
Ruetschi, Maja S.4/4/20115 Years%4/4/201176FR18556
Ryan, Patrick T.11/29/1994Permanent^11/29/199459FR60992
  FR Correction01/17/199560FR03451
Sacher, Robert E.08/11/1997Permanent^08/11/199762FR42998
Santos, Armando11/10/201412 years %11/10/201479FR66728
Sardesai, Suhas V.09/30/2003Permanent^09/30/200368FR56299
Sawaya, Mary E. a.k.a. Marty Sawaya06/12/2009Permanent^06/12/200974FR28049
Schetlick, Gloria H.04/26/1993Permanent^04/26/199358FR21983
Martinez-Seldon, Deborah10/5/2011Permanent^10/5/201176FR61712
Seldon, Stephen Lee5/27/2011Permanent^5/27/201176FR30947
Shah, Atul12/05/1994Permanent^*12/05/199459FR62399
 03/11/1997Sp.Trmnation+03/11/199762FR11212
Shah, Dilip08/31/1993Permanent^*08/31/199358FR45899
Shah, Satish R.08/01/1994Permanent^*08/01/199459FR38983
Shah, Shashikant04/05/20125 years %04/05/201277FR20639
Shainfeld, Frederick Jay03/10/1995Permanent^#02/28/199661FR07521
Sharp, Lisa Jean08/23/2012Permanent^08/23/201277FR56647
Shrum, Kelly Dean08/23/2012Permanent^08/23/201277FR51030
****Shulman, Robert NMI08/27/1993Permanent^08/27/199358FR45340
Snyder, Jr., Harry W.01/13/2003Permanent^01/13/200368FR1619
Soto, Kelvin10/20/20146 years %10/20/201479FR62634
Spencer, Wayne E.09/13/2012Permanent^09/13/201277FR56646
Striefsky, Edmund J.09/30/2003Permanent^09/30/200368FR56300
Sturm, Jan T.06/22/1993Permanent^06/22/199358FR33941
  FR Correction07/06/199358FR36252
Theodore, Thomas Ronald08/05/2003Permanent^08/05/200368FR46197
Torgerson, Michelle Lynn11/13/2009Permanent^11/13/200974FR58639
Uddin, Mohammad NMI09/29/2000Permanent^09/29/200065FR58557
Ullom, Brian2/2/2010Permanent^2/2/201075FR5332
Vale, Jason1/12/2010Permanent^1/12/201075FR1623
Van Wormer, Mark E.3/10/2011Permanent^3/10/201176FR13192
Vegesna, Raju04/12/1993Permanent^04/12/199358FR19129
Wells, Ivyl W.4/19/2011Permanent^4/19/201176FR21910
Xu, Kevin4/8/2010Permanent^4/8/201075FR17927
Yanikian, Sami Arshak07/02/201210 years %07/02/201277FR39245
Yoser, Seth M.5/20/2010Permanent^8/18/201075FR51079

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
**
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.

Page Last Updated: 11/14/2014
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