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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

Dailey

Matthew

03/17/2020

10 years%

03/17/2020

85 FR 15193

Jodoin

Robert

03/17/2020

5 years%

03/17/2020

85 FR 15195

Komar

Keith

10/20/2020

5 years%

10/20/2020

85 FR 66568

Lee

John Seil

07/24/2020

10 years%

07/24/2020

85 FR 44907

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

Park

Jin Su

07/24/2020

10 years%

07/24/2020

85 FR 44904

Tran

Tuan Anh

11/30/2020

5 years%

11/30/2020

85 FR 76583

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

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

 

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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