FDA Debarment List (Drug Imports)
FDA Debarment List (Drug Import Debarment)
The following is a public list of firms or persons currently debarred pursuant to sections 306(b)(3)(C) or (D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(b)(3)(C) or (D)) 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
|
Last Name |
First & Middle Names |
Effective Date |
End/Term of Debarment |
FR Date.txt (MM/DD/YY) |
Volume Page.pdf |
|
Ash |
Justin | 07/28/2021 | 5 years% | 07/28/2021 | 86 FR 40579 |
|
Dailey |
Matthew |
03/17/2020 |
10 years% |
03/17/2020 |
|
|
Fees |
Julia | 12/15/2021 | 5 years% | 12/15/2021 | |
|
Jodoin |
Robert |
03/17/2020 |
5 years% |
03/17/2020 |
|
|
Komar |
Keith |
10/20/2020 |
5 years% |
10/20/2020 |
|
|
Kulakevich |
William | 1/4/2022 |
5 years% |
1/4/2022 | 87 FR 225 |
|
Lee |
John Seil |
07/24/2020 |
10 years% |
07/24/2020 |
|
|
Lewicki |
Jagen |
03/17/2020 |
5 years% |
03/17/2020 |
|
|
Lexier |
Tzvi |
11/29/2019 |
10 years% |
11/29/2019 |
|
|
Park |
Jin Su |
07/24/2020 |
10 years% |
07/24/2020 |
|
|
Shepard |
Rick |
05/14/2021 |
5 years% |
05/14/2021 |
|
|
Tran |
Tuan Anh |
11/30/2020 |
5 years% |
11/30/2020 |
|
|
Whalen |
Thomas J. |
03/26/2021 |
10 years% |
03/26/2021 |
|
|
Wing |
Ursula |
03/26/2021 |
5 years% |
03/26/2021 |
% 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.
This list is prepared by ORA's Division of Enforcement,: 12420 Parklawn Drive, Rockville, Maryland 20857; email: [email protected].
Additional references:
- Clinical Investigators - Disqualification Proceedings
- The Public Health Service Administrative Actions Listing
- FEDERAL REGISTER (publications from 1994 to date)
- Debarment certification statements: Draft guidance for industry (PDF)
Please note: Hyperlinks to FEDERAL REGISTER statements are provided where available. Debarments prior to 1994 are not available online.