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  1. FDA Debarment List (Drug Product Applications)

FDA Debarment List (Drug Imports)

FDA Debarment List (Drug Import Debarment)

The following is a public list of firms or persons currently debarred pursuant to sections 306(b)(3)(C) or (D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(b)(3)(C) or (D)) as published in the FEDERAL REGISTER (http://www.gpoaccess.gov/fr/) (FR).

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

Last Name

First & Middle Names

Effective Date

End/Term of Debarment

FR Date.txt (MM/DD/YY)

Volume Page.pdf

Ash

Justin 07/28/2021 5 years% 07/28/2021 86 FR 40579
Bishop Patrick Charles 01/04/2021 5 years% 03/03/2022

87 FR 12172

Dailey

Matthew

03/17/2020

10 years%

03/17/2020

85 FR 15193

Fees

Julia 12/15/2021 5 years% 12/15/2021

86 FR 71271

Funaro

James

12/19/2023

5 years%

12/19/2023

88 FR 87784

Gagne

Brendon

02/09/2024

5 years%

02/09/2024

89 FR 9158

Godding    

Linda L. 01/20/2023 5 years% 01/20/2023 88 FR 3747

Godding

Mark A. 01/20/2023 5 years% 01/20/2023 88 FR 3744
Hampton-Bey II Kris A. 07/13/2022 5 years% p 07/13/2022 87 FR 41725
Head, Jr. Howard Stanley 05/17/2022 5 years% 05/17/2022 87 FR 28867

Jodoin

Robert

03/17/2020

5 years%

03/17/2020

85 FR 15195

Kempema David J. 12/14/2022 5 years% 12/14/2022

87 FR 76490

Knoll    

Ildiko M.

08/15/2023

5 years% p

08/15/2023

88 FR 55461

Komar

Keith

10/20/2020

5 years%

10/20/2020

85 FR 66568

Kulakevich

William 1/4/2022

5 years%

1/4/2022 87 FR 225
Kuiper George 03/03/2022 5 years% 03/03/2022

87 FR 12174

Lee

John Seil

07/24/2020

10 years%

07/24/2020

85 FR 44907

Leonowens

Phillip

03/26/2024

5 years%

03/26/2024

89 FR 20978

Lesniak

Wojciech 02/27/2023 5 years% p 02/27/2023 88 FR 12381

Lewicki

Jagen

03/17/2020

5 years%

03/17/2020

85 FR 15190

Lexier

Tzvi

11/29/2019

10 years%

11/29/2019

84 FR 65825

Little Michael Terry 06/03/2024 5 years% 06/03/2024

89 FR 47576

Lucien Ross 02/14/2024 5 years% 02/14/2024

89 FR 11298

Marmas

Brenda Kay

02/10/2022

5 years% p

02/10/2022

87 FR 7840

McLaren

Taylor

02/23/2024

5 years%

02/23/2024

89 FR 13722

Mendoza

David Elias 11/15/2022 5 years% p 11/15/2022 87 FR 69503

Momin

Irfanali Nisarali 03/22/2022 5 years% 03/22/2022 87 FR 16214
Momin Shiba I. 03/22/2022 5 years% 03/22/2022

87 FR 16215

Moran

Luis Anarbol 06/12/2023 5 years% 06/12/2023 88 FR 380 59

Nagy

Adam Michael

12/15/2023

15 years%

12/15/2023

88 FR 86906

Novikov

Jhanna 07/07/2022 5 years% 07/07/2022 87 FR 40539

Park

Jin Su

07/24/2020

10 years%

07/24/2020

85 FR 44904

Parks   

Brian Michael   

02/14/2022

5 years%

02/14/2022

87 FR 8264

Punjani Shanif Abdul 06/03/2024 5 years% 06/03/2024

89 FR 47565

Shepard

Rick

05/14/2021

5 years%

05/14/2021

86 FR 26523

Shuffert Robert 04/05/2024 5 years% 04/05/2024

89 FR 24013

Sievert Marina 06/06/2024 10 years% 06/06/2024

89 FR 48432

Smith

Richard B.

06/13/2024

5 years%

06/13/2024

89 FR 50344

Staley

Jennings Ryan 10/06/2022 5 years% 11/29/2022 87 FR 73315

Tran

Tuan Anh

11/30/2020

5 years% p

11/30/2020

85 FR 76583

Walenty

Jeremy

12/19/2023

5 years%

12/19/2023

88 FR 87785

Whalen

Thomas J.

03/26/2021

10 years%

03/26/2021

86 FR 16222

Wing

Ursula

03/26/2021

5 years%

03/26/2021

86 FR 16226

Zipperer

Kenneth 07/25/2022 5 years% 07/25/2022 86 FR 44128

NOTATIONS:

% Permissive Debarment (Sec. 306(b))

* Hearing requested and denied.

# Acquiesced to Debarment.

aka Also known as

NMI No Middle Initial known to be used

Debarment based on a pattern of importing or offering for import

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:

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

 

 
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