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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FDA Debarment List (Food Importation)

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

Firms

NAME OF FIRMEFFECTIVE DATEEND/TERM
OF DEBARMENT		FR DATE.txt
(MM/DD/YY)		VOLUME PAGE.pdf
None as of this date    

 

Persons

NAME OF PERSONEFFECTIVE DATEEND/TERM
OF DEBARMENT		FR DATE.txt
(MM/DD/YY)		VOLUME PAGE.pdf
Blyth, Karen L. a.k.a. Karen Leigh Dougan Blyth05/07/201220 years %05/07/201277FR26766
Bonnes, John04/19/201005 years %08/13/201075FR49497
Fan, Hung Ta8/16/20115 years%8/16/201176FR50739
Ho, Su Van08/26/201015 years %08/26/201075FR52534
Izurieta, Anneri01/13/201230 years %01/13/201277FR2070
Izurieta, Yuri01/25/201220 years %01/25/201277FR3776
Lam, Peter Xuong12/14/200920 years %12/14/200974FR66133
Phelps, David H.M.05/07/201220 years %05/07/201277FR26765

 

NOTATIONS:

%   Permissive Debarment (Sec. 306(b))
*   Hearing requested and denied.
#   Acquiesced to Debarment.
+   Special Termination of Debarment (Sec. 306(d)(4)(C) and (d)(4)(D))
++  Order to Withdraw Order of Debarment (debarment terminated) (Sec. 306(d)(3)(B)(i))
!!! Rescission of Debarment Order
akaAlso known as
NMINo 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.

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 the left hand side 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 the Office of Enforcement, Division of Compliance Policy (HFC-230), 5600 Fishers Lane, Rockville, Maryland 20857; telephone 240.632.6860; FAX 240.632.6861.

Additional references:

The Disqualified/Restricted/Assurance List for Clinical Investigators

The Public Health Service Administrative Actions Listing

FEDERAL REGISTER (publications from 1994 to date)

Debarment certification statements: Draft guidance for industry (PDF)

Background information on Debarment: ["FDA Consumer" magazine March 1997 "Inside FDA:Barring People from the Drug Industry"]

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

 

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