Import Alert 99-50

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 99-50

Published Date: 04/18/2024

Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Product Imported by Debarred Entities

Reason for Alert:

Section 301(cc) of the FD&C Act [21 USC 331(cc)] prohibits "[t]he importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred from such activity under section 306(b)(3) [21 USC 335a(b)(3)] of this title." Section 306(b)(3) authorizes FDA to debar persons for conduct relating to the illegal importation of food and drugs.

Prohibited imports are subject to refusal under section 801(a)(5) of the FD&C Act [21 USC 381(a)(5)] which states that FDA shall refuse an article if it appears that "such article is being imported or offered for import in violation of section 301(cc) [21 USC 331(cc)] of this title."

Guidance:

Divisions may detain, without physical examination, article(s) offered for import by a debarred entity either identified on the Red List of this import alert or within this section.

Divisions should review the terms of the debarment order to identify the person who is debarred and determine whether the importation is in violation of the debarment order under section 306(b)(3). (Note: Links to the FDA Debarment Lists are below.) If a non-debarred person is offering the product for import, but it appears that a debarred person is assisting or directing such activity, Divisions should contact oraoeiodiodebarments@fda.hhs.gov in order to determine next steps. If the debarment order only applies to an individual associated with a firm who is not an owner or in a director or executive position in the firm and FDA does not have information that the debarred individual offered the article for import or assisted with or directed such activity, then the article is not subject to refusal under section 805(a)(5) of the FD&C Act (but note that there may be other reasons why the article may be subject to refusal).

Section 801(k) of the FD&C Act [[21 USC 381(k)] also provides FDA with authority to hold food imported or offered for import by a debarred person. This food may be delivered only to a non-debarred person who affirmatively establishes that the food complies with the FD&C Act. If there are questions about whether the provisions in 801(k) are applicable, the Divisions should consult with oraoeiodiodebarments@fda.hhs.gov.

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

In order to remove a debarred entity from the Red List, documentation should be provided to indicate that the entity has resolved the conditions that gave rise to the appearance of the violation (e.g., the person is no longer subject to a debarment order under section 306(b)(3) of the FD&C Act). If the detention is a result of importing or offering for import of an article of food or a drug with the assistance of, or at the direction of a debarred firm or individual, persons may provide evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved (such as documentation to demonstrate that the debarred entity is not involved in the importation of the listed FDA regulated product).

If a firm and/or a representative would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov.

FDA's Debarment Lists are publicly available on FDA's internet site and provide any interested party information regarding agency debarments. The dates of the debarment period are listed on the pages. If the terms of the debarment permit the debarred entity to resume business on a future date, the term ending date can be identified on the list(s). Divisions may consult the publicly available FDA Debarment Lists for conduct related to importation using the following links:

FDA Debarment List (Drug Imports): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-debarment-list-drug-product-applications/fda-debarment-list-drug-imports

FDA Debarment List (Food Imports): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-debarment-list-drug-product-applications/fda-debarment-list-food-importation

Debarred Individuals (Drugs):

Last Name First and Middle Names Effective Date End Date

Whalen Thomas J. 3/26/2021 3/26/2031

Lee John Seil 7/24/2020 7/24/2030

Park Jin Su 7/24/2020 7/24/2030

Dailey Matthew 3/17/2020 3/17/2030

Lexier Tzvi 11/29/2019 11/29/2029

Head, Jr. Howard Stanley 5/17/2022 5/17/2027

Momin Irfanali Nisarali 3/22/2022 3/22/2027

Momin Shiba I. 3/22/2022 3/22/2027

Kuiper George 3/3/2022 3/3/2027

Parks Brian Michael 2/14/2022 2/14/2027

Marmas Brenda Kay 2/10/2022 2/10/2027

Kulakevich William 1/4/2022 1/4/2027

Fees Julia 12/15/2021 12/15/2026

Ash Justin 7/28/2021 7/28/2026

Shepard Rick 5/14/2021 5/14/2026

Wing Ursula 3/26/2021 3/26/2026

Bishop Patrick Charles 1/4/2021 1/4/2026

Tran Tuan Anh 11/30/2020 11/30/2025

Komar Keith 10/20/2020 10/20/2025

Jodoin Robert 3/17/2020 3/17/2025

Lewicki Jagen 3/17/2020 3/17/2025

Novikov Jhanna 7/7/2022 7/7/2027

Hampton-BeyII Kris 7/13/2022 7/13/2027

Zipperer Kenneth 7/25/2022 7/25/2027

Mendoza David Elias 11/15/2022 11/15/2027

Staley Jennings Ryan 10/6/2022 10/6/2027

Kempema David J. 12/14/2022 12/14/2027

Godding Mark 01/20/2023 01/20/2028

Godding Linda 01/20/2023 01/20/2028

Lesniak Wojciech 02/27/2023 02/27/2028

Moran Luis Anarbol 06/12/2023 06/12/2028

Knoll Ildiko M. 08/15/2023 08/15/2028

Nagy Adam Michael 12/15/2023 12/15/2038

Funaro James P. 12/19/2023 12/19/2028

Walenty Jeremy 12/19/2023 12/19/2028

Gagne Brendon 02/09/2024 02/09/2029

Lucien Ross 02/14/2024 02/14/2029

McLaren Taylor 02/23/2024 02/23/2029

Leonowens Phillip 03/26/2024 03/26/2029

Shuffert Robert Lance 04/05/2024 04/05/2029

Debarred Individuals (Foods):

Last Name First & Middle Names Effective Date End Date

Blyth,a.k.a. Karen Leigh
Dougan Blyth Karen L. 5/17/2012 5/7/2032

Phelps David H.M 5/7/2021 5/7/2024

Lam Peter Xuong 12/14/2009 12/14/2024

Lin,a.k.a Hung Yi 2/18/2015 2/18/2035
Katy Lin

Parks Brian Michael 2/14/2022 2/14/2042

Styron. Jeffrey A. 12/15/2021 12/15/2026

Patel Sitesh Bansi 10/1/2021 10/1/2026

Hebert Matthew 7/30/2021 7/30/2026

Geissler Jacobo 7/28/2021 7/28/2026

Doyle Jonathan 7/26/2021 7/26/2026

Carawan Phillip R. 10/23/2020 10/23/2025

Ho Su Van 8/26/2010 8/26/2015

Casey Michael P. 3/18/2020 3/18/2025

Dong Zhang X. 3/17/2020 3/17/2025

Casey James R. 11/29/2019 11/29/2024

Tuccillo, Sr Roy 9/23/2022 9/23/2027

Tuccillo, Jr Roy 9/23/2022 9/23/2027

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving import debarments should be addressed to the Division of Import Operations (DIO) at oraoeiodiodebarments@fda.hhs.gov.

Product Description:

All food and or drug products (See the Red List for specific individual(s)/firm(s) combinations).

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(5) of the Federal Food, Drug, and Cosmetic Act in that the article is being imported or offered for import with the assistance of, or at the direction of, a person debarred from such activity. [Prohibited, Section 301(cc)]."

OASIS charge code: DEBAR

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)

UNITED STATES

Captain Neills Seafood

Date Published : 04/18/2024

508 N Road St , Columbia, NC 27925-8949 UNITED STATES

02 - - - -- Whole Grains/Milled Grain Products/Starches

Date Published: 04/18/2024