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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 Person

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

Akhigbe, Ehigiator O.

12/17/2010

25 Year%

12/17/2010

75FR79005

Albanese, Anthony W.

11/23/2009

Permanent^

11/23/2009

74FR61151

Aminzada, Mirwaiss

06/22/2015

Permanent^

06/22/2015

80FR35652

Anthony, James Michael

11/07/1997

Permanent^

11/07/1997

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^

08/28/1997

62FR45667

Bhandari, Ranjan

12/27/2018

3 Years %

12/27/2018

83FR66717

Bhutani, Baldev Raj

12/02/2004

Permanent^

12/02/2004

69FR70148

Brown, Raymond Sean

02/17/2017

Permanent^

02/17/2017

82FR11044

Bushlow, John W.

03/22/1996

Permanent^*

03/22/1996

61FR11846

Butkovitz, Anne L.

10/17/2006

Permanent^

10/17/2006

71FR61061

Campbell, Maria Anne Kirkman

09/02/2008

Permanent ^

09/02/2008

73FR51305

Chang, Charles Y.

03/08/1993

Permanent^

03/08/1993

58FR12967

 

 

FR Correction

04/26/1993

58FR21983

Colton, Steven F.

06/17/1993

Permanent^*

06/17/1993

58FR33446

Copanos, John D.

03/11/1996

Permanent^*

03/11/1996

61FR09711

 

 

FR Correction

04/18/1996

61FR16975

Coroniti, Lisa Marie

08/20/2015

Permanent^

08/20/2015

80FR50636

Courtney, Robert Ray

10/20/2003

Permanent^

10/20/2003

68FR59942

Delong, Karis Copper

2/17/2017

12 years %

2/17/2017

82FR11045

DeLuca Jr., William F.

03/05/2015

5 years%

03/05/2015

80FR12011

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

Durr, Patricia

07/09/2015

Permanent^

07/09/2015

80FR39439

Elbert, Robert

04/03/1997

Permanent^*

04/03/1997

62FR15902

Elsharaiha, Rami

09/29/2000

Permanent^

09/29/2000

65FR58555

Fernandez, Odalys

03/31/2015

6 years%

03/31/2015

80FR17049

Fleming, Richard M.

9/28/2018

10 years %

9/28/2018

83FR49095

Fiddes, Robert A.

11/06/2002

20 years%

11/06/2002

67FR67628

 

01/21/2003

FR Correction

01/21/2003

58FR2784

Finelli, Gena R.

04/21/1993

Permanent^

04/21/1993

58FR21469

Fishman, David J.

12/11/2018

3 years %

12/11/2018

83FR63657

Fogari, Robert A.

07/08/1993

Permanent^*

07/08/1993

58FR36691

Garfinkel, Barry D.

04/02/1997

Permanent^*

04/02/1997

162FR1573

Gil, Isachi

10/17/2018

6 years %

10/17/2018

83FR52487

Girdhari, Premchand

01/21/2000

Permanent^*

01/21/2000

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^

10/17/1997

62FR54117

Hossain, Liaquat

11/05/1993

Permanent^*

11/05/1993

58FR59046

Huda, Syed

09/16/2015

Permanent^

09/16/2015

80FR55632

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

Khan, Talib

07/08/2015

Permanent^

07/08/2015

80FR39121

Kimball, James T.

01/30/2007

Permanent ^

01/30/2007

72FR4269

Kincaid, William Ralph

1/18/2018

Permanent ^

1/18/2018

832FR2641

Kindness, George J.

11/24/2008

Permanent ^

11/24/2008

73FR71007

Kletch, Walter S.

11/29/1994

Permanent^*

11/29/1994

59FR60989

Kokes, Edwin

04/30/2003

Permanent^

04/30/2003

68FR23138

Kornak, Paul H.

08/04/2009

Permanent^

08/04/2009

74FR38657

Kostas, Constantine I.

06/25/1998

Permanent^*

06/10/1998

63FR34652

Kuo, Su-Chiao

12/11/2018

3 years %

12/11/2018

83FR63656

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

Mannan, Muhammad Z.

04/06/1993

Permanent^

04/06/1993

58FR17896

Manookian, Edward a.k.a. Ed Manning

11/14/2016

Permanent^

11/14/2016

81FR79501

Marks, Stephen L.

02/22/2012

Permanent^

02/22/2012

77FR10533

Martinez-Seldon, Deborah

10/5/20111

Permanent^

10/5/2011

76FR61712

McCoy, John D.

9/28/2018

4 years %

9/28/2018

83FR49099

McQuerry, Wesley A.

3/18/2016

Permanent^

3/18/2016

81FR14862

Mendell, Arnold S.

12/21/1994

Permanent^*

12/21/1994

59FR65773

Morris, Andrew

05/16/1994

Permanent^#

01/11/1995

60FR02767

Nathan, Ray

8/9/2011

Permanent^

8/09/2011

76FR48869

Nguyen, Trang Doan

10/24/2017

5 years%

10/24/2017

82FR49211

Page, Roy C.

11/24/2008

Permanent ^

11/24/2008

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

***Patel, Ashok

11/08/1994

Permanent^*

11/08/1994

59FR55670

Patel, Dilip

9/27/2018

5 years %

9/27/2018

83FR48829

Petrik, Craig H.

04/30/2002

Permanent^

04/30/2002

67FR21255

Peugeot, Renee

01/13/2003

Permanent^

01/13/2003

68FR1619

Pierce, Keith J.

12/21/2017

5 Years %

12/21/2017

82FD60611

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^#

12/30/1994

59FR67709

Rana, Nandlal

10/20/1997

Permanent^

10/20/1997

62FR54462

Reuben, Scott S.

11/16/2011

Permanent^

11/16/2011

76FR71042

Rivers, Jacob H.

04/12/1993

Permanent^

04/12/1993

58FR19128

Rodriguez, Juan Manuel

07/26/1993

Permanent^

07/26/1993

58FR39819

Rothenberg, Gayle

11/8/2011

Permanent^

11/8/2011

76FR69272

Ryan, Patrick T.

11/29/1994

Permanent^

11/29/1994

59FR60992

 

 

FR Correction

01/17/1995

60FR03451

Sacher, Robert E.

08/11/1997

Permanent^

08/11/1997

62FR42998

Santos, Armando

11/10/2014

12 years %

11/10/2014

79FR66728

Sardesai, Suhas V.

09/30/2003

Permanent^

09/30/2003

68FR56299

Sarraf, Anoushirvan

06/22/2015

Permanent^

06/22/2015

80FR35653

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

Schroeder, Matthew   

10/26/2017

Permanent^

10/26/2017

82FR49634

Seldon, Stephen Lee

5/27/2011

Permanent^

5/27/2011

76FR30947

Shah, Dilip

08/31/1993

Permanent^*

08/31/1993

58FR45899

Shah, Satish R.

08/01/1994

Permanent^*

08/01/1994

59FR38983

Shah, Shashikant

04/05/2012

5 years %

04/05/2012

77FR20639

Shainfeld, Frederick Jay

03/10/1995

Permanent^#

02/28/1996

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

Singh, Paul S.

11/15/2016

Permanent^

11/15/2016

81F80073

Smith, Louis Daniel   

11/15/2016

Permanent^

11/15/2016

81FR80077

Snyder, Jr., Harry W.

01/13/2003

Permanent^

01/13/2003

68FR1619

Soto, Kelvin

10/20/2014

6 years %

10/20/2014

79FR62634

Spencer, Wayne E.

09/13/2012

Permanent^

09/13/2012

77FR56646

Striefsky, Edmund J.

09/30/2003

Permanent^

09/30/2003

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^

08/05/2003

68FR46197

Torgerson, Michelle Lynn

11/13/2009

Permanent^

11/13/2009

74FR58639

Uddin, Mohammad NMI

09/29/2000

Permanent^

09/29/2000

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.

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 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