Inspections, Compliance, Enforcement, and Criminal Investigations

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 FIRM 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
Blyth, Karen L. a.k.a. Karen Leigh Dougan Blyth 05/07/2012 20 years % 05/07/2012 77FR26766
Bonnes, John 04/19/2010 05 years % 08/13/2010 75FR49497
Delaney, Stephen C. 10/5/2011 5 years% 10/5/2011 77FR61003
Fan, Hung Ta 8/16/2011 5 years% 8/16/2011 76FR50739
Ho, Su Van 08/26/2010 15 years % 08/26/2010 75FR52534
Izurieta, Anneri 07/17/2013 Withdrawn++ 07/17/2013 78FR42787
Izurieta, Yuri 07/17/2013 Withdrawn++ 07/17/2013 78FR42787
Lam, Peter Xuong 12/14/2009 20 years % 12/14/2009 74FR66133
Phelps,David H.M. 05/07/2012 20 years % 05/07/2012 77FR26765
Stowell, Richard 02/26/2013 3 years % 02/26/2013 78FR13068
Vela, Adrian 03/5/2013 5 years % 03/5/2013 78FR14304
Yuan, Shu Bei 03/18/2013 5 years % 03/18/2013 78FR16680

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
aka
Also known as
aka
Also known as
NMI
No 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.

Page Last Updated: 08/27/2014
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