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 In this section:

        Compliance Actions and Activities

FDA Debarment List (Drug Product Applications)

                        
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          FDA Debarment List (Drug Product Applications)Compliance Actions and Activities FDA Debarment List (Drug Product Applications)
  	
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Below is a public list of firms or persons currently debarred pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)) as published in the FEDERAL REGISTER (http://www.gpoaccess.gov/fr/) (FR). A listing of persons previously debarred can be found at this link.

Firms

Name of Firm
			Effective Date
			End/Term of Debarment
			FR Date.txt (MM/DD/YY)
			Volume Page.pdfNone as of this date

Persons

Last Name
			First & Middle Names
			Effective Date
			End/Term of Debarment
			FR Date.txt (MM/DD/YY)
			Volume Page.pdfAkhigbe
			Ehigiator O.
			12/17/2010
			25 Year%
			12/17/2010
			75 FR 79005Albanese
			Anthony W.
			11/23/2009
			Permanent^
			11/23/2009
			74 FR 61151Aminzada
			Mirwaiss
			06/22/2015
			Permanent^
			06/22/2015
			80 FR 35652Anthony
			James Michael
			11/07/1997
			Permanent^
			11/07/1997
			62 FR 60249Anwar
			Sami
			02/02/2023
			Permanent^
			02/02/2023
			88 FR 7093Azeem
			Mohammed
			04/26/1993
			Permanent^
			04/26/1993
			58 FR 21982~FR Correction
			05/05/1993
			58 FR 26814~Babich
			Michael L.
			11/27/2020
			Permanent^
			11/27/2020
			85 FR 76084Bae
			Kun Chae
			12/30/1993
			Permanent^*
			12/30/1993
			58 FR 69368~Banks
			Norma D.
			08/28/1997
			Permanent^
			08/28/1997
			62 FR 45667Baxter
			Timothy
			02/27/2023
			5 Years%
			02/27/2023
			88 FR 12369Bhutani
			Baldev Raj
			12/02/2004
			Permanent^
			12/02/2004
			69 FR 70148Brown
			Raymond Sean
			02/17/2017
			Permanent^
			02/17/2017
			82 FR 11044Burklakoff
			Alec
			01/04/2021
			Permanent^
			01/04/2021
			86 FR 102Bushlow
			John W.
			03/22/1996
			Permanent^*
			03/22/1996
			61 FR 11846Butkovitz
			Anne L.
			10/17/2006
			Permanent^
			10/17/2006
			71 FR 61061Cadden
			Barry J.
			11/30/2020
			Permanent^
			11/30/2020
			85 FR 76582Campbell
			Maria Anne Kirkman
			09/02/2008
			Permanent ^
			09/02/2008
			73 FR 51305Chang
			Charles Y.
			03/08/1993
			Permanent^
			03/08/1993
			58 FR 12967~FR Correction
			04/26/1993
			58 FR 21983~Colton
			Steven F.
			06/17/1993
			Permanent^*
			06/17/1993
			58 FR 33446~Copanos
			John D.
			03/11/1996
			Permanent^*
			03/11/1996
			61 FR 09711FR Correction
			04/18/1996
			61 FR 16975Coroniti
			Lisa Marie
			08/20/2015
			Permanent^
			08/20/2015
			80 FR 50636Courtney
			Robert Ray
			10/20/2003
			Permanent^
			10/20/2003
			68 FR 59942Daffin
			Diana
			07/27/2023
			Permanent^
			07/27/2023
			88 FR 48473Delong
			Karis Copper
			2/17/2017
			12 years %
			2/17/2017
			82 FR 11045Desai
			Kanubhai C.
			10/06/1993
			Permanent^
			10/06/1993
			58 FR 52111~Diaz
			Daylen
			06/21/2023
			Permanent^
			06/21/2023
			88 FR 40275Dicola
			Charles G.
			11/05/1993
			Permanent^*
			11/05/1993
			58 FR 59044~**Donnelly
			Mary
			11/29/1993
			Permanent^
			11/29/1993
			58 FR 62675~Durr
			Patricia
			07/09/2015
			Permanent^
			07/09/2015
			80 FR 39439Edwards
			Brenda E.
			03/19/2020
			Permanent^
			03/19/2020
			85 FR 15791Edwards
			Charles J.
			03/18/2020
			Permanent^
			03/18/2020
			85 FR 15481Elbert
			Robert
			04/03/1997
			Permanent^*
			04/03/1997
			62 FR 15902Elmer
			Paul J.
			07/24/2020
			Permanent^
			07/24/2020
			85 FR 44899Elsharaiha
			Rami
			09/29/2000
			Permanent^
			09/29/2000
			65 FR 58555Figueroa
			Raidel
			08/03/2023
			Permanent^
			08/03/2023
			88 FR 51328Fleming
			Richard M.
			9/28/2018
			10 years %
			9/28/2018
			83 FR 49095Finelli
			Gena R.
			04/21/1993
			Permanent^
			04/21/1993
			58 FR 21469~Fogari
			Robert A.
			07/08/1993
			Permanent^*
			07/08/1993
			58 FR 36691~Garfinkel
			Barry D.
			04/02/1997
			Permanent^*
			04/02/1997
			162 FR 1573Gil
			Isachi
			10/17/2018
			6 years %
			10/17/2018
			83 FR 52487Girdhari
			Premchand
			01/21/2000
			Permanent^*
			01/21/2000
			65 FR 03454Gonsalves, Jr.
			Wallace
			10/21/2009
			Permanent^
			10/21/2009
			74 FR 54051Gurry
			Michael
			03/21/2021
			Permanent^
			03/21/2021
			86 FR 12473Hendrick
			Kim C.
			08/04/2009
			Permanent^
			08/04/2009
			74 FR 38656Herman
			Hedviga
			10/17/1997
			Permanent^
			10/17/1997
			62 FR 54117Hossain
			Liaquat
			11/05/1993
			Permanent^*
			11/05/1993
			58 FR 59046~Huda
			Syed
			09/16/2015
			Permanent^
			09/16/2015
			80 FR 55632Justice
			Glen R.
			07/09/2012
			25 years %
			07/09/2012
			77 FR 40366Kalinoski
			Stephen
			03/19/2020
			Permanent^
			03/19/2020
			85 FR 15792Kane
			Niaja
			11/23/2009
			Permanent^
			11/23/2009
			74 FR 61150Kapoor
			John
			11/30/2020
			Permanent^
			11/30/2020
			85 FR 76581Khan
			Talib
			07/08/2015
			Permanent^
			07/08/2015
			80 FR 39121Kimball
			James T.
			01/30/2007
			Permanent ^
			01/30/2007
			72 FR 4269Kincaid
			William Ralph
			1/18/2018
			Permanent ^
			1/18/2018
			83 FR 2641Kindness
			George J.
			11/24/2008
			Permanent ^
			11/24/2008
			73 FR 71007Kletch
			Walter S.
			11/29/1994
			Permanent^*
			11/29/1994
			59 FR 60989~Kokes
			Edwin
			04/30/2003
			Permanent^
			04/30/2003
			68 FR 23138Kornak
			Paul H.
			08/04/2009
			Permanent^
			08/04/2009
			74 FR 38657Kostas
			Constantine I.
			06/25/1998
			Permanent^*
			06/10/1998
			63 FR 34652Laing
			Euton
			07/24/2020
			Permanent^
			07/24/2020
			85 FR 44898Lais
			Patrick J.
			2/23/2010
			Permanent^
			2/23/2010
			75 FR 8081Lee
			Sunrise
			01/04/2021
			Permanent^
			01/04/2021
			86 FR 100Lentini
			Jerome
			05/09/2012
			Permanent^*
			05/09/2012
			77 FR 27235Letizia, Jr.
			Gabriel
			01/18/2023
			Permanent^
			01/18/2023
			88 FR 2935Liang
			Cheng Yi
			03/06/2013
			Permanent^
			03/06/2013
			78 FR 14556Lledo
			Maytee
			11/23/2021
			Permanent^
			11/23/2021
			86 FR 66566Long
			Susan M.
			12/23/1993
			Permanent^*
			12/23/1993
			58 FR 68147~Mannan
			Muhammad Z.
			04/06/1993
			Permanent^
			04/06/1993
			58 FR 17896~Manookian, a.k.a. Ed Manning
			Edward
			11/14/2016
			Permanent^
			11/14/2016
			81 FR 79501Marks
			Stephen L.
			02/22/2012
			Permanent^
			02/22/2012
			77 FR 10533Martinez-Seldon
			Deborah
			10/5/2011
			Permanent^
			10/5/2011
			76 FR 61712Massouh
			Marwan
			05/11/2022
			3 years %
			05/11/2022
			87 FR 28834McQuerry
			Wesley A.
			3/18/2016
			Permanent^
			3/18/2016
			81 FR 14862Mendell
			Arnold S.
			12/21/1994
			Permanent^*
			12/21/1994
			59 FR 65773Morris
			Andrew
			05/16/1994
			Permanent^#
			01/11/1995
			60 FR 02767Nathan
			Ray
			8/9/2011
			Permanent^
			8/09/2011
			76 FR 48869Navarro
			Eduardo
			03/03/2022
			Permanent^
			03/03/2022
			87 FR 12171Ngo
			Belen G.
			08/02/2021
			5 years%*
			08/02/2021
			86 FR 41486Page
			Roy C.
			11/24/2008
			Permanent ^
			11/24/2008
			73 FR 71008Pai, a.k.a. Lau, Daphne
			Daphne
			11/05/1993
			Permanent^*
			11/05/1993
			58 FR 59048~Palaparty
			Poornanand
			01/25/2023
			3 years%
			01/25/2023
			88 FR 4830Palazzo
			Maria Carmen
			4/6/2011
			Permanent^
			4/6/2011
			76 FR 19100***Patel
			Ashok
			11/08/1994
			Permanent^*
			11/08/1994
			59 FR 55670~Petrik
			Craig H.
			04/30/2002
			Permanent^
			04/30/2002
			67 FR 21255Peugeot
			Renee
			01/13/2003
			Permanent^
			01/13/2003
			68 FR 1619Poet
			Albert
			03/03/2011
			Permanent^
			03/03/2011
			76 FR 11789Prasad
			Kumar
			06/30/1993
			Permanent^
			06/30/1993
			58 FR 35006~Quamruzzaman
			Abu
			11/18/1993
			Permanent^#
			12/30/1994
			59 FR 67709~Rana
			Nandlal
			10/20/1997
			Permanent^
			10/20/1997
			62 FR 54462Raventos
			Listett
			04/14/2022
			Permanent^
			04/14/2022
			87 FR 22218Reuben
			Scott S.
			11/16/2011
			Permanent^
			11/16/2011
			76 FR 71042Reinhard
			Mark
			04/14/2021
			Permanent^
			04/14/2021
			86 FR 19625Rico
			Analay
			06/08/2023
			Permanent^
			06/08/2023
			88 FR 37546Rivers
			Jacob H.
			04/12/1993
			Permanent^
			04/12/1993
			58 FR 19128~Rodriguez
			Juan Manuel
			07/26/1993
			Permanent^
			07/26/1993
			58 FR 39819~Rothenberg
			Gayle
			11/8/2011
			Permanent^
			11/8/2011
			76 FR 69272Rowan
			Joseph A.
			01/04/2021
			Permanent^
			01/04/2021
			86 FR 103Ryan
			Patrick T.
			11/29/1994
			Permanent^
			11/29/1994
			59 FR 60992~FR Correction
			01/17/1995
			60 FR 03451Ryan
			Lawrence B.
			03/21/2021
			Permanent^
			03/21/2021
			86 FR 12482Sacher
			Robert E.
			08/11/1997
			Permanent^
			08/11/1997
			62 FR 42998Santos
			Armando
			11/10/2014
			12 years %
			11/10/2014
			79 FR 66728Sardesai
			Suhas V.
			09/30/2003
			Permanent^
			09/30/2003
			68 FR 56299Sarraf
			Anoushirvan
			06/22/2015
			Permanent^
			06/22/2015
			80 FR 35653Sawaya, a.k.a. Marty Sawaya
			Mary E.
			06/12/2009
			Permanent^
			06/12/2009
			74 FR 28049Schetlick
			Gloria H.
			04/26/1993
			Permanent^
			04/26/1993
			58 FR2 1983~Schroeder
			Matthew
			10/26/2017
			Permanent^
			10/26/2017
			82 FR 49634Seldon
			Stephen Lee
			5/27/2011
			Permanent^
			5/27/2011
			76FR30947Shah
			Dilip
			08/31/1993
			Permanent^*
			08/31/1993
			58 FR 45899~Shah
			Satish R.
			08/01/1994
			Permanent^*
			08/01/1994
			59 FR 38983~Settino
			Gregory
			10/18/2022
			Permanent^*
			10/18/2022
			87 FR 63076Shainfeld
			Frederick Jay
			03/10/1995
			Permanent^#
			02/28/1996
			61 FR 07521Sharp
			Lisa Jean
			08/23/2012
			Permanent^
			08/23/2012
			77 FR 56647Shrum
			Kelly Dean
			08/23/2012
			Permanent^
			08/23/2012
			77 FR 51030****Shulman
			Robert
			08/27/1993
			Permanent^
			08/27/1993
			58 FR 45340~Simon
			Richard M.
			11/19/2020
			Permanent^
			11/192020
			85 FR 73726Singh
			Paul S.
			11/15/2016
			Permanent^
			11/15/2016
			81 FR 80073Smith
			Jerrod Nichols
			01/04/2021
			Permanent^
			01/04/2021
			86 FR 101Smith
			Louis Daniel
			11/15/2016
			Permanent^
			11/15/2016
			81 FR 80077Snyder, Jr.
			Harry W.
			01/13/2003
			Permanent^
			01/13/2003
			68 FR 1619Spencer
			Wayne E.
			09/13/2012
			Permanent^
			09/13/2012
			77 FR 56646Striefsky
			Edmund J.
			09/30/2003
			Permanent^
			09/30/2003
			68 FR 56300Sturm
			Jan T.
			06/22/1993
			Permanent^
			06/22/1993
			58 FR 33941~FR Correction
			07/06/1993
			58 FR 36252~Tahsildar
			Hassan
			02/08/2023
			2 years%
			02/08/2023
			88 FR 8292Tatsene
			Mayya
			09/12/2023
			Permanent^
			09/12/2023
			88 FR 62575Tejeda
			Duniel
			08/02/2022
			Permanent^
			08/02/2022
			87 FR 47218Thaxter
			Shaun
			02/27/2023
			5 years%
			02/27/2023
			88 FR 12375Theodore
			Thomas Ronald
			08/05/2003
			Permanent^
			08/05/2003
			68 FR 46197Tighe
			Gerald
			03/19/2020
			Permanent^
			03/19/2020
			85 FR 15790Torgerson
			Michelle Lynn
			11/13/2009
			Permanent^
			11/13/2009
			74 FR 58639Torres
			Olga L.
			04/12/2023
			Permanent^
			04/12/2023
			88 FR 22043Uddin
			Mohammad
			09/29/2000
			Permanent^
			09/29/2000
			65 FR 58557Ullom
			Brian
			2/2/2010
			Permanent^
			2/2/2010
			75 FR 5332Vale
			Jason
			1/12/2010
			Permanent^
			1/12/2010
			75 FR 1623Van Wormer
			Mark E.
			3/10/2011
			Permanent^
			3/10/2011
			76 FR 13192Varona
			Nayade
			03/15/2022
			Permanent^
			03/15/2022
			87 FR 14539Vegesna
			Raju
			04/12/1993
			Permanent^
			04/12/1993
			58 FR 19129~Wells
			Ivyl W.
			4/19/2011
			Permanent^
			4/19/2011
			76 FR 21910Winne
			David
			08/18/2023
			Permanent^
			08/18/2023
			88 FR 5663611/01/2023
			Sp.Termination (08/17/2024)
			11/01/2023
			88 FR 74999Villaman-Bencosme
			Yvelice
			4/19/2022
			Permanent^
			4/19/2022
			87 FR 23184Xu
			Kevin
			4/8/2010
			Permanent^
			4/8/2010
			75 FR 17927Yoser
			Seth M.
			5/20/2010
			Permanent^
			8/18/2010
			75 FR 51079

NOTATIONS:

^          Mandatory Debarment (Sec. 306(a))

%         Permissive Debarment (Sec. 306(b))

*          Hearing requested and denied.

#          Acquiesced to Debarment.

aka      Also known as

*NMI*     No Middle Initial known to be used

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

**        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 nor with Ashok Shankarbhai Patel of Allegan, MI, currently affiliated with Perrigo Company.

****    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.

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.

                                                                                  Content current as of:
      12/01/2023FDA Debarment List (Drug Product Applications)                
                          

                        FDA Debarment List (Drug Imports)
          FDA Debarments (Food Imports)
          FDA Debarment List Updates
 
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