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  1. FDA Debarment List (Drug Product Applications)

FDA Debarment List (Drug Imports)

The following is a public list of firms or persons currently debarred pursuant to sections 306(b)(3)(A) or (B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(b)(3)(A) or (B)) 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

Name of Person

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
Lewicki, Jagen 03/17/2020 5 years % 03/17/2020 85 FR 15190

Lexier, Tzvi

11/29/2019

 10 years %

11/29/2019

 84FR65825

 

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.

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