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U.S. Department of Health and Human Services

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

 
03/11/1997 Sp.Trmnation+ 62FR11212
Berman, David E. 3/9/2011 3 Years%
3/9/2011
76FR12971
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

 
06/11/1998 Sp.Trmnation+ 63FR32013
Choi, Andrew K. 8/08/2011 4 years%
8/08/2011
76FR48168
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
Diamond, Bruce I. 11/14/2013 10 years %
11/14/2013
78FR68455
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
Foyle, Ashley Brandon 05/01/2013 5 years% 03/18/2013 78FR25456
Freeman, David 05/08/2013 5 years% 05/08/2013 78FR26784
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
Liang, Cheng Yi 03/06/2013 Permanent^
03/06/2013
78FR14556
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
Parikh, Jyotin 04/06/2012 5 years % 04/06/2012 77FR20823
***Patel, Ashok 11/08/1994 Permanent^* 59FR55670
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
Shrum, Kelly Dean 08/23/2012 Permanent^
08/23/2012
77FR51030
****Shulman, Robert NMI 08/27/1993 Permanent^
08/27/1993
58FR45340
Snyder, Jr., Harry W. 01/13/2003 Permanent^ 68FR1619
Spencer, Wayne E. 09/13/2012 Permanent^ 09/13/2012 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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