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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 FIRMEFFECTIVE DATEEND/TERM
OF DEBARMENT
FR DATE.txt
(MM/DD/YY)
VOLUME PAGE.pdf

None as of this date

 

  

 

Persons

 

NAME OF PERSONEFFECTIVE DATEEND/TERM
OF DEBARMENT
FR DATE.txt
(MM/DD/YY)
VOLUME PAGE.pdf
Aiache, Adrien E.5/27/20115 years%
5/27/2011
76FR30946
Akhigbe, Ehigiator O.12/17/201025 Year%
12/17/2010
75FR79005
Albanese, Anthony W.11/23/2009Permanent^
11/23/2009
74FR61151
Anthony, James Michael11/07/1997Permanent^62FR60249
Azeem, Mohammed04/26/1993Permanent^
04/26/1993
58FR21982

 

 
FR Correction
05/05/1993
58FR26814
Bae, Kun Chae12/30/1993Permanent^*
12/30/1993
58FR69368
Banks, Norma D.08/28/1997Permanent^62FR45667
Bansal, Padam C.11/29/1993Permanent^*
11/29/1993
58FR62674

 
03/11/1997Sp.Trmnation+62FR11212
Berman, David E.3/9/20113 Years%
3/9/2011
76FR12971
Bhutani, Baldev Raj12/02/2004Permanent^69FR70148
Borison, Richard L.09/30/200310 years%68FR56298
Brancato, David J.01/06/1994Permanent^*59FR00751
Bushlow, John W.03/22/1996Permanent^*61FR11846
Butkovitz, Anne L.10/17/2006Permanent^71FR61061
Campbell, Maria Anne Kirkman09/02/2008Permanent ^73FR51305
Caro Acevedo, Eduardo03/24/20055 years%70FR15107
Chang, Charles Y.03/08/1993Permanent^
03/08/1993
58FR12967

 

 
FR Correction
04/26/1993
58FR21983
Charpentier, Laverne M.12/02/20025 years%*67FR71574
Chatman, Cathryn Lyn a.k.a. Cathryn Lyn Garcia4/7/20115 years%
4/7/2011
76FR19373
Chatterji, Dulal C.11/01/1995Permanent^#62FR03297
Choi, Andrew K.8/08/20114 years%
8/08/2011
76FR48168

 
06/11/1998Sp.Trmnation+63FR32013
Cioffi, Albert Ronald10/25/20115 years%
10/25/2011
76FR66072
Colton, Steven F.06/17/1993Permanent^*
06/17/1993
58FR33446
Concepcion, Jose04/05/20125 years %04/05/201277FR20641
Copanos, John D.03/11/1996Permanent^*61FR09711

 

 
FR Correction61FR16975
Courtney, Robert Ray10/20/2003Permanent^68FR59942
Desai, Kanubhai C.10/06/1993Permanent^
10/06/1993
58FR52111
Diamond, Bruce I.11/14/201310 years %
11/14/2013
78FR68455
Dicola, Charles G.11/05/1993Permanent^*
11/05/1993
58FR59044
**Donnelly, Mary11/29/1993Permanent^
11/29/1993
58FR62675
Elbert, Robert04/03/1997Permanent^*62FR15902
Elsharaiha, Rami09/29/2000Permanent^65FR58555
Feuer, Scott06/02/19985 years%63FR31789
Fiddes, Robert A.11/06/200220 years%67FR67628

 
01/21/2003FR Correction58FR2784
Finelli, Gena R.04/21/1993Permanent^
04/21/1993
58FR21469
Fogari, Robert A.07/08/1993Permanent^*
07/08/1993
58FR36691
Foyle, Ashley Brandon05/01/20135 years%03/18/201378FR25456
Freeman, David05/08/20135 years%05/08/201378FR26784
Garfinkel, Barry D.04/02/1997Permanent^*162FR1573
Girdhari, Premchand01/21/2000Permanent^*65FR03454
Gonsalves, Jr., Wallace10/21/2009Permanent^
10/21/2009
74FR54051
Hendrick, Kim C.08/04/2009Permanent^
08/04/2009
74FR38656
Herman, Hedviga10/17/1997Permanent^62FR54117
Holland, James A.3/4/20105 years%*
3/4/2010
75FR9904
Hossain, Liaquat11/05/1993Permanent^*
11/05/1993
58FR59046
Islam, Amirul08/27/1997Permanent^#62FR45423

 
10/09/2003Sp. Trmnation+68FR58352
Justice, Glen R.07/09/201225 years %
07/09/2012
77FR40366
Kalidindi, Sanyasi Raju04/21/1993Permanent^
04/21/1993
58FR21470
Kane, Niaja11/23/2009Permanent^
11/23/2009
74FR61150
Kimball, James T.01/30/2007Permanent ^
01/30/2007
72FR4269
Kindness, George J.11/24/2008Permanent ^73FR71007
Kletch, Walter S.11/29/1994Permanent^*59FR60989
Knott, Susan F.12/11/20122 years %12/11/201277FR73663
Kokes, Edwin04/30/2003Permanent^68FR23138
Kornak, Paul H.08/04/2009Permanent^
08/04/2009
74FR38657
Kostas, Constantine I.06/25/1998Permanent^*63FR34652
Lai, Elaine Yee-Ling11/13/20025 years%67FR68877

 

 
FR Correction68FR03264
Lais, Patrick J.
 
2/23/2010
 
Permanent^
2/23/2010
75FR8081
Lentini, Jerome05/09/2012Permanent^*
05/09/2012
77FR27235
Liang, Cheng Yi03/06/2013Permanent^
03/06/2013
78FR14556
Long, Susan M.12/23/1993Permanent^*
12/23/1993
58FR68147
Macwan, Ashish04/05/20125 years %
04/05/2012
77FR20638
Mannan, Muhammad Z.04/06/1993Permanent^
04/06/1993
58FR17896
Marcus, Jay09/29/20005 years%65FR58556
Marks, Stephen L.02/22/2012Permanent^
02/22/2012
77FR10533
Matkari, Rajaram K.10/20/1993Permanent^*
10/20/1993
58FR54156

 
06/13/2000Withdrawn++65FR37154
Mays, Gary D.01/24/19975 years%62FR03703
Mehlmauer, Marilyn A.4/4/20114 years%
4/4/2011
76FR18557
Mendell, Arnold S.12/21/1994Permanent^*59FR65773
Morris, Andrew05/16/1994Permanent^#60FR02767
Nathan, Ray8/9/2011Permanent^
8/09/2011
76FR48869
Norman, Allyn M.06/12/20095 years%
06/12/2009
74FR28050
One person removed
from list
11/06/2002Rescission!!!68FR2339
Page, Roy C.11/24/2008Permanent ^73FR71008
Pai, Daphne (aka Lau, Daphne)11/05/1993Permanent^*
11/05/1993
58FR59048
Palazzo, Maria Carmen4/6/2011Permanent^
4/6/2011
76FR19100
Panagotacos, Daphne I.05/09/20125 Years %*
05/09/2012
77FR27236
Pappas, Anastasios3/9/20115 Years%
3/9/2011
76FR12971
***Patel, Ashok11/08/1994Permanent^*59FR55670
Parikh, Jyotin04/06/20125 years %04/06/201277FR20823
Perkal, Mark B.11/29/1993Permanent^
11/29/1993
58FR62676

 
09/11/1998Sp.Trmnation+63FR48733
Petrik, Craig H.04/30/2002Permanent^67FR21255
Peugeot, Renee01/13/2003Permanent^68FR1619
Poet, Albert03/03/2011Permanent^03/03/201176FR11789
Prasad, Kumar06/30/1993Permanent^
06/30/1993
58FR35006
Quamruzzaman, Abu11/18/1993Permanent^#59FR67709
Rana, Nandlal10/20/1997Permanent^62FR54462
Reuben, Scott S.11/16/2011Permanent^
11/16/2011
76FR71042
Rivers, Jacob H.04/12/1993Permanent^
04/12/1993
58FR19128
Rodgers, Jr., Thomas M.07/28/20055 years%71FR43699
Rodriguez, Juan Manuel07/26/1993Permanent^
07/26/1993
58FR39819
Rosio, Timothy J.6/24/20114 years%
6/24/2011
76FR37126
Rothenberg, Gayle11/8/2011Permanent^
11/8/2011
76FR69272
Ruetschi, Maja S.4/4/20115 Years%
4/4/2011
76FR18556
Ryan, Patrick T.11/29/1994Permanent^59FR60992

 

 
FR Correction60FR03451
Sacher, Robert E.08/11/1997Permanent^62FR42998
Sardesai, Suhas V.09/30/2003Permanent^68FR56299
Sawaya, Mary E. a.k.a. Marty Sawaya06/12/2009Permanent^
06/12/2009
74FR28049
Schetlick, Gloria H.04/26/1993Permanent^
04/26/1993
58FR21983
Martinez-Seldon, Deborah10/5/2011Permanent^
10/5/2011
76FR61712
Seldon, Stephen Lee5/27/2011Permanent^
5/27/2011
76FR30947
Shah, Atul12/05/1994Permanent^*59FR62399

 
03/11/1997Sp.Trmnation+62FR11212
Shah, Dilip08/31/1993Permanent^*
08/31/1993
58FR45899
Shah, Satish R.08/01/1994Permanent^*59FR38983
Shah, Shashikant04/05/20125 years %04/05/201277FR20639
Shainfeld, Frederick Jay03/10/1995Permanent^#61FR07521
Sharp, Lisa Jean08/23/2012Permanent^
08/23/2012
77FR56647
****Shulman, Robert NMI08/27/1993Permanent^
08/27/1993
58FR45340
Shrum, Kelly Dean08/23/2012Permanent^
08/23/2012
77FR51030
Snyder, Jr., Harry W.01/13/2003Permanent^68FR1619
Spencer, Wayne E.09/13/2012Permanent^77FR56646
Striefsky, Edmund J.09/30/2003Permanent^68FR56300
Sturm, Jan T.06/22/1993Permanent^
06/22/1993
58FR33941

 

 
FR Correction
07/06/1993
58FR36252
Theodore, Thomas Ronald08/05/2003Permanent^68FR46197
Torgerson, Michelle Lynn11/13/2009Permanent^
11/13/2009
74FR58639
Uddin, Mohammad NMI09/29/2000Permanent^65FR58557
Ullom, Brian2/2/2010Permanent^
2/2/2010
75FR5332
Vale, Jason1/12/2010Permanent^
1/12/2010
75FR1623
Van Wormer, Mark, E.3/10/2011Permanent^
3/10/2011
76FR13192
Vegesna, Raju04/12/1993Permanent^
04/12/1993
58FR19129
Wells, Ivyl W.4/19/2011Permanent^
4/19/2011
76FR21910
Xu, Kevin4/8/2010Permanent^
4/8/2010
75FR17927
Yanikian, Sami Arshak07/02/201210 years %
07/02/2012
77FR39245
Yoser, Seth M.5/20/2010Permanent^
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
akaAlso known as
NMINo 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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