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FDA Debarment List (Drug Product Applications)

FDA Debarment List (Drug Product Applications)

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.pdf

None as of this date

 

 

 

 

 

Persons

Last Name

First & Middle Names

Effective Date

End/Term of Debarment

FR Date.txt (MM/DD/YY)

Volume Page.pdf

Akhigbe

Ehigiator O.

12/17/2010

25 Year%

12/17/2010

75 FR 79005

Albanese

Anthony W.

11/23/2009

Permanent^

11/23/2009

74 FR 61151

Aminzada

Mirwaiss

06/22/2015

Permanent^

06/22/2015

80 FR 35652

Anthony

James Michael

11/07/1997

Permanent^

11/07/1997

62 FR 60249

Azeem

Mohammed

04/26/1993

Permanent^

04/26/1993

58 FR 21982~

 

 

 

FR Correction

05/05/1993

58 FR 26814~

Bae

Kun Chae

12/30/1993

Permanent^*

12/30/1993

58 FR 69368~

Banks

Norma D.

08/28/1997

Permanent^

08/28/1997

62 FR 45667

Bhandari

Ranjan

12/27/2018

3 Years %

12/27/2018

83 FR 66717

Bhutani

Baldev Raj

12/02/2004

Permanent^

12/02/2004

69 FR 70148

Brown

Raymond Sean

02/17/2017

Permanent^

02/17/2017

82 FR 11044

Bushlow

John W.

03/22/1996

Permanent^*

03/22/1996

61 FR 11846

Butkovitz

Anne L.

10/17/2006

Permanent^

10/17/2006

71 FR 61061

Campbell

Maria Anne Kirkman

09/02/2008

Permanent ^

09/02/2008

73 FR 51305

Chang

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 09711

 

 

 

FR Correction

04/18/1996

61 FR 16975

Coroniti

Lisa Marie

08/20/2015

Permanent^

08/20/2015

80 FR 50636

Courtney

Robert Ray

10/20/2003

Permanent^

10/20/2003

68 FR 59942

Delong

Karis Copper

2/17/2017

12 years %

2/17/2017

82 FR 11045

Desai

Kanubhai C.

10/06/1993

Permanent^

10/06/1993

58 FR 52111~

Diamond

Bruce I.

11/14/2013

10 years %

11/14/2013

78 FR 68455

Dicola

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 39439

Edwards

Brenda E.

03/19/2020

Permanent^

03/19/2020

85 FR 15791

Edwards

Charles J.

03/18/2020

Permanent^

03/18/2020

85 FR 15481

Elbert

Robert

04/03/1997

Permanent^*

04/03/1997

62 FR 15902

Elmer Paul J. 07/24/2020 Permanent^ 07/24/2020 85 FR 44899

Elsharaiha

Rami

09/29/2000

Permanent^

09/29/2000

65 FR 58555

Fernandez

Odalys

03/31/2015

6 years%

03/31/2015

80 FR 17049

Fleming

Richard M.

9/28/2018

10 years %

9/28/2018

83 FR 49095

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

Finelli

Gena R.

04/21/1993

Permanent^

04/21/1993

58 FR 21469~

Fishman

David J.

12/11/2018

3 years %

12/11/2018

83 FR 63657

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 1573

Gil

Isachi

10/17/2018

6 years %

10/17/2018

83 FR 52487

Girdhari

Premchand

01/21/2000

Permanent^*

01/21/2000

65 FR 03454

Gonsalves, Jr.

Wallace

10/21/2009

Permanent^

10/21/2009

74 FR 54051

Hendrick

Kim C.

08/04/2009

Permanent^

08/04/2009

74 FR 38656

Herman

Hedviga

10/17/1997

Permanent^

10/17/1997

62 FR 54117

Hossain

Liaquat

11/05/1993

Permanent^*

11/05/1993

58 FR 59046~

Huda

Syed

09/16/2015

Permanent^

09/16/2015

80 FR 55632

Justice

Glen R.

07/09/2012

25 years %

07/09/2012

77 FR 40366

Kalidindi

Sanyasi Raju

04/21/1993

Permanent^

04/21/1993

58 FR 21470~

Kalinoski

Stephen

03/19/2020

Permanent^

03/19/2020

85 FR 15792

Kane

Niaja

11/23/2009

Permanent^

11/23/2009

74 FR 61150

Khan

Talib

07/08/2015

Permanent^

07/08/2015

80 FR 39121

Kimball

James T.

01/30/2007

Permanent ^

01/30/2007

72 FR 4269

Kincaid

William Ralph

1/18/2018

Permanent ^

1/18/2018

83 FR 2641

Kindness

George J.

11/24/2008

Permanent ^

11/24/2008

73 FR 71007

Kletch

Walter S.

11/29/1994

Permanent^*

11/29/1994

59 FR 60989~

Kokes

Edwin

04/30/2003

Permanent^

04/30/2003

68 FR 23138

Kornak

Paul H.

08/04/2009

Permanent^

08/04/2009

74 FR 38657

Kostas

Constantine I.

06/25/1998

Permanent^*

06/10/1998

63 FR 34652

Kuo

Su-Chiao

12/11/2018

3 years %

12/11/2018

83FR63656

Laing Euton 07/24/2020 Permanent^ 07/24/2020 85 FR 44898

Lais

Patrick J.

2/23/2010

Permanent^

2/23/2010

75 FR 8081

Lentini

Jerome

05/09/2012

Permanent^*

05/09/2012

77 FR 27235

Liang

Cheng Yi

03/06/2013

Permanent^

03/06/2013

78 FR 14556

Long

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 79501

Marks

Stephen L.

02/22/2012

Permanent^

02/22/2012

77 FR 10533

Martinez-Seldon

Deborah

10/5/20111

Permanent^

10/5/2011

76 FR 61712

McCoy

John D.

9/28/2018

4 years %

9/28/2018

83 FR 49099

McQuerry

Wesley A.

3/18/2016

Permanent^

3/18/2016

81 FR 14862

Mendell

Arnold S.

12/21/1994

Permanent^*

12/21/1994

59 FR 65773

Morris

Andrew

05/16/1994

Permanent^#

01/11/1995

60 FR 02767

Nathan

Ray

8/9/2011

Permanent^

8/09/2011

76 FR 48869

Nguyen

Trang Doan

10/24/2017

5 years%

10/24/2017

82 FR 49211

Page

Roy C.

11/24/2008

Permanent ^

11/24/2008

73 FR 71008

Pai, a.k.a. Lau, Daphne

Daphne

11/05/1993

Permanent^*

11/05/1993

58 FR 59048~

Palazzo

Maria Carmen

4/6/2011

Permanent^

4/6/2011

76 FR 19100

***Patel

Ashok

11/08/1994

Permanent^*

11/08/1994

59 FR 55670~

Patel

Dilip

9/27/2018

5 years %

9/27/2018

83 FR 48829

Petrik

Craig H.

04/30/2002

Permanent^

04/30/2002

67 FR 21255

Peugeot

Renee

01/13/2003

Permanent^

01/13/2003

68 FR 1619

Pierce

Keith J.

12/21/2017

5 Years %

12/21/2017

82FD60611

Poet

Albert

03/03/2011

Permanent^

03/03/2011

76 FR 11789

Prasad

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 54462

Reuben

Scott S.

11/16/2011

Permanent^

11/16/2011

76 FR 71042

Rivers

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 69272

Ryan

Patrick T.

11/29/1994

Permanent^

11/29/1994

59 FR 60992~

 

 

 

FR Correction

01/17/1995

60 FR 03451

Sacher

Robert E.

08/11/1997

Permanent^

08/11/1997

62 FR 42998

Santos

Armando

11/10/2014

12 years %

11/10/2014

79 FR 66728

Sardesai

Suhas V.

09/30/2003

Permanent^

09/30/2003

68 FR 56299

Sarraf

Anoushirvan

06/22/2015

Permanent^

06/22/2015

80 FR 35653

Sawaya, a.k.a. Marty Sawaya

Mary E.

06/12/2009

Permanent^

06/12/2009

74 FR 28049

Schetlick

Gloria H.

04/26/1993

Permanent^

04/26/1993

58 FR2 1983~

Schroeder 

Matthew  

10/26/2017

Permanent^

10/26/2017

82 FR 49634

Seldon

Stephen Lee

5/27/2011

Permanent^

5/27/2011

76FR30947

Shah

Dilip

08/31/1993

Permanent^*

08/31/1993

58 FR 45899~

Shah

Satish R.

08/01/1994

Permanent^*

08/01/1994

59 FR 38983~

Shainfeld

Frederick Jay

03/10/1995

Permanent^#

02/28/1996

61 FR 07521

Sharp

Lisa Jean

08/23/2012

Permanent^

08/23/2012

77 FR 56647

Shrum

Kelly Dean

08/23/2012

Permanent^

08/23/2012

77 FR 51030

****Shulman

Robert

08/27/1993

Permanent^

08/27/1993

58 FR 45340~

Singh

Paul S.

11/15/2016

Permanent^

11/15/2016

81 FR 80073

Smith

Louis Daniel   

11/15/2016

Permanent^

11/15/2016

81 FR 80077

Snyder, Jr.

Harry W.

01/13/2003

Permanent^

01/13/2003

68 FR 1619

Soto

Kelvin

10/20/2014

6 years %

10/20/2014

79 FR 62634

Spencer

Wayne E.

09/13/2012

Permanent^

09/13/2012

77 FR 56646

Striefsky

Edmund J.

09/30/2003

Permanent^

09/30/2003

68 FR 56300

Sturm

Jan T.

06/22/1993

Permanent^

06/22/1993

58 FR 33941~

 

 

 

FR Correction

07/06/1993

58 FR 36252~

Theodore

Thomas Ronald

08/05/2003

Permanent^

08/05/2003

68 FR 46197

Tighe

Gerald

03/19/2020

Permanent^

03/19/2020

85 FR 15790

Torgerson

Michelle Lynn

11/13/2009

Permanent^

11/13/2009

74 FR 58639

Uddin

Mohammad

09/29/2000

Permanent^

09/29/2000

65 FR 58557

Ullom

Brian

2/2/2010

Permanent^

2/2/2010

75 FR 5332

Vale

Jason

1/12/2010

Permanent^

1/12/2010

75 FR 1623

Van Wormer

Mark E.

3/10/2011

Permanent^

3/10/2011

76 FR 13192

Vegesna

Raju

04/12/1993

Permanent^

04/12/1993

58 FR 19129~

Wells

Ivyl W.

4/19/2011

Permanent^

4/19/2011

76 FR 21910

Xu

Kevin

4/8/2010

Permanent^

4/8/2010

75 FR 17927

Yanikian

Sami Arshak

07/02/2012

10 years %

07/02/2012

77 FR 39245

Yoser

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 at govinfo.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.

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:

Please note: Hyperlinks to FEDERAL REGISTER statements are provided where available. Debarments prior to 1994 are not available online.

 

Resources For You

 



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