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  1. FDA Debarment List (Drug Product Applications)

FDA Debarments (Food Imports)

FDA Debarment List (Food Import Debarment)

 

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).

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

Captain Neill's Seafood, Inc.

10/23/2020

5 years %

10/23/2020

85 FR 67552

Meunerie Sawyerville, Inc.   

3/1/2018

5 years %

3/1/2018

83FR8877

Persons

Last Name

First & Middle Names

Effective Date

End/Term of Debarment

FR Date.txt (MM/DD/YY)

Volume Page.pdf

Blyth, a.k.a. Karen Leigh Dougan Blyth

Karen L.

05/07/2012

20 years %

05/07/2012

77 FR 26766

Carawan

Phillip R.

10/23/2020

5 years %

10/23/2020

85 FR 67553

Casey

James R.

11/29/2019

5 years %

11/29/2019

84 FR 65819

Casey

Michael P.

03/18/2020

5 years %

03/18/2020

 

85 FR 15480

Dong

Zhang X.

03/17/2020

5 years %

03/17/2020

 

85 FR 15191

Ho

Su Van

08/26/2010

15 years %

08/26/2010

75 FR 52534

Lam

Peter Xuong

12/14/2009

20 years %

12/14/2009

74 FR 66133

Lin, a.k.a. Katy Lin

Hung Yi

02/18/2015

12 years%

02/18/2015

80 FR 8664

Liu

Chung Po

07/07/2015

5 years %

07/07/2015

80 FR 38696

Phelps

David H.M.

05/07/2012

20 years %

05/07/2012

77 FR 26765

NOTATIONS:

%         Permissive Debarment (Sec. 306(b))

*          Hearing requested and denied.

#          Acquiesced to Debarment.

!!!        Rescission of Debarment Order

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

Notice of Opportunity for Hearing (NOOH)

 

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