FDA Expired Debarment List (Drug Product Applications)

FDA Expired Debarment List (Drug Product Applications)

Below is a public list of firms or persons whose debarment pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)) has either expired or has been terminated.

Firms

Name of Firm	Effective Date	End/Term of Debarment	FR Date.txt (MM/DD/YY)	Volume Page.pdf
None at this time

Persons

Last Name	First & Middle Names	Effective Date	End/Term of Debarment	FR Date.txt (MM/DD/YY)	Volume Page.pdf
Last Name	First & Middle Names	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	76 FR 30946
Bansal	Padam C.	11/29/1993	Permanent^*	11/29/1993	58 FR 62674~
		03/11/1997	Sp.Trmnation+	03/11/1997	62 FR 11212
Berman	David E.	3/9/2011	3 Years %	3/9/2011	76 FR 12971
Bhandari	Ranjan	12/27/2018	3 years%	12/27/2018	83 FR 66717
Borison	Richard L.	09/30/2003	10 years%	09/30/2003	68 FR 56298
Brancato	David J.	01/06/1994	Permanent^*	01/06/1994	59FR00751
		7/20/2015	Sp.Termination+	6/22/2015	80 FR 42826
Caro Acevedo	Eduardo	03/24/2005	5 years%	03/24/2005	70 FR 15107
Charpentier	Laverne M.	12/02/2002	5 years%*	12/02/2002	67 FR 71574
Chatman, a.k.a. Cathryn Lyn Garcia	Cathryn Lyn	4/7/2011	5 years%	4/7/2011	76 FR 19373
Chatterji	Dulal C.	11/01/1995	Permanent^#	01/22/1997	62 FR 03297
		06/11/1998	Sp.Trmnation+	06/11/1998	63 FR 32013
Choi	Andrew K.	8/08/2011	4 years%	8/08/2011	76 FR 48168
Cioffi	Albert Ronald	10/25/2011	5 years%	10/25/2011	76 FR 66072
Concepcion	Jose	04/05/2012	5 years %	04/05/2012	77 FR 20641
DeLuca, Jr.	William F.	03/05/2015	5 years%	03/05/2015	80 FR 12011
Diamond	Bruce I.	11/14/2013	10 years %	11/14/2013	78 FR 68455
Fernandez	Odalys	3/31/2015	6 years%	3/31/2015	80 FR 17049
Feuer	Scott	06/02/1998	5 years%	06/10/1998	63 FR 31789
Fiddes	Robert A.	11/06/2002	20 years%	11/06/2002	67 FR 67628
		01/21/2003	FR Correction	01/21/2003	58 FR 2784
Fishman	David J.	12/11/2018	3 years%	12/11/2018	83 FR 63657
Foyle	Ashley Brandon	05/01/2013	5 years%	03/18/2013	78 FR 25456
Freeman	David	05/08/2013	5 years%	05/08/2013	78 FR 26784
Gil	Isachi	10/17/2018	6 years %	10/17/2018	83 FR 52487
Hargrave	Douglas M.	03/05/2015	2 years%	03/05/2015	80 FR 11995
Holland	James A.	3/4/2010	5 years%*	3/4/2010	75 FR 9904
Islam	Amirul	08/27/1997	Permanent^#	08/27/1997	62 FR 45423
		10/09/2003	Sp. Trmnation+	10/09/2003	68 FR 58352
Kalidindi	Sanyasi Raju	04/21/1993	Permanent^	04/21/1993	58 FR 21470~
		11/16/2021	Sp. Trmnation+	11/16/2021	86 FR 63401
Knott	Susan F.	12/11/2012	2 years %	12/11/2012	77 FR 73663
Kuo	Su-Chiao	12/11/2018	3 years%	12/11/2018	83FR63656
Lai	Elaine Yee-Ling	11/13/2002	5 years%	11/13/2002	67 FR 68877
			FR Correction	11/23/2003	68 FR 03264
Lynch	Steven M.	03/05/2015	2 years%	03/05/2015	80 FR 12013
Macwan	Ashish	04/05/2012	5 years %	04/05/2012	77 FR 20638
Marcus	Jay	09/29/2000	5 years%	09/29/2000	65 FR 58556
Matkari	Rajaram K.	10/20/1993	Permanent^*	10/20/1993	58 FR 54156~
		06/13/2000	Withdrawn++	06/13/2000	65 FR 37154
Mays	Gary D.	01/24/1997	5 years%	01/24/1997	62 FR 03703
McCoy	John D	9/28/2018	4 years %	9/28/2018	83 FR 49099
Mehlmauer	Marilyn A.	4/4/2011	4 years%	4/4/2011	76 FR 18557
Moffett	Mark	01/25/2023	Permanent^	01/25/2023	88 FR 4826
		07/14/2023	Withdrawn++	07/14/2023	88 FR 45228
Nguyen	Trang Doan	10/24/2017	5 years%	10/24/2017	82 FR 49211
Noonan	John D.	03/05/2015	2 years%	03/05/2015	80 FR 12007
Norman	Allyn M.	06/12/2009	5 years%	06/12/2009	74 FR 28050
One person removed from list		11/06/2002	Rescission!!!	01/16/2003	68 FR 2339
Panagotacos	Daphne I.	05/09/2012	5 Years %*	05/09/2012	77 FR 27236
Pappas	Anastasios	3/9/2011	5 Years%	3/9/2011	76 FR 12971
Parikh	Jyotin	04/06/2012	5 years %	04/06/2012	77 FR 20823
Patel	Dilip	9/27/2018	5 years %	9/27/2018	83 FR 48829
Patel	Vithal K.	08/02/2021	1 year %	08/02/2021	86 FR 41483
Perkal	Mark B.	11/29/1993	Permanent^	11/29/1993	58 FR 62676~
		09/11/1998	Sp.Trmnation+	09/11/1998	63 FR48733
Pierce	Keith J.	12/21/2017	5 Years %	12/21/2017	82FD60611
Rockmore	Jeffrey L.	03/05/2015	2 years%	03/05/2015	80 FR 11991
Rodgers, Jr.	Thomas M.	07/28/2005	5 years%	07/28/2005	71 FR 43699
Rosio	Timothy J.	6/24/2011	4 years%	6/24/2011	76FR37126
Ruetschi	Maja S.	4/4/2011	5 Years%	4/4/2011	76 FR 18556
Shah	Atul	12/05/1994	Permanent^*	12/05/1994	59 FR 62399~
		03/11/1997	Sp.Trmnation+	03/11/1997	62 FR 11212
Shah	Shashikant	04/05/2012	5 years %	04/05/2012	77 FR 20639
Soto	Kelvin	10/20/2014	6 years %	10/20/2014	79 FR 62634
Yanikian	Sami Arshak	07/02/2012	10 years %	07/02/2012	77 FR 39245

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

~ Federal Register Documents dating before 1995 are available via PDF at govinfo.gov

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 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 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.

ResourcesForYou

• Notice of Opportunity for Hearing (NOOH)