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  1. FDA Debarment List (Drug Product Applications)

FDA Debarments (Food Imports)

FDA debarment is a legal action that prohibits individuals and entities from participating in certain activities related to FDA-regulated industries such as FDA-regulated product application submission approval or FDA-regulated product importation, typically after a conviction for serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA debarment lists help the public identify if an applicant has been debarred or sanctioned for abuse, fraud, or integrity issues.
 

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 FirmEffective DateEnd/Term of DebarmentFR Date.txt (MM/DD/YY)Volume Page.pdf
Captain Neill's Seafood, Inc.10/23/20205 years %10/23/202085 FR 67552

Persons

Last NameFirst & Middle
Names
Effective
Date
End/Term of
Debarment
FR Date.txt
(MM/DD/YY)
Volume Page.pdf
Blyth, a.k.a. Karen Leigh Dougan BlythKaren L.05/07/201220 years %05/07/201277 FR 26766
CarawanPhillip R.10/23/20205 years %10/23/202085 FR 67553
CaseyMichael P.03/18/20205 years %03/18/202085 FR 15480
DongZhang X.03/17/20205 years %03/17/202085 FR 15191
DoyleJonathan07/26/20215 years %07/26/202186 FR 40063
FangKevin Sheng Hsiang11/19/20245 years%11/19/202489 FR 91408
GeisslerJacobo07/28/20215 years%07/28/202186 FR 40592
HebertMatthew07/30/20215 years%07/30/202186 FR 41042
HoSu Van08/26/201015 years %08/26/201075 FR 52534
LamPeter Xuong12/14/200920 years %12/14/200974 FR 66133
Lin, a.k.a. Katy LinHung Yi02/18/201512 years%02/18/201580 FR 8664
ParksBrian Michael02/14/20225 years%02/14/202287 FR 8264
PatelSitesh Bansi10/01/20215 years%10/01/202186 FR 54456
PhelpsDavid H.M.05/07/201220 years %05/07/201277 FR 26765
StyronJeffrey A.12/15/20215 years%12/15/202186 FR 71270
Tuccillo, Sr.Roy09/23/20225 years%09/23/202287 FR 58109
Tuccillo, JrRoy09/23/20225 years%09/23/202287 FR 58108

%         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.

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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