1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. JMT Inter LLC - 718661 - 02/19/2026
  1. Warning Letters

WARNING LETTER

JMT Inter LLC MARCS-CMS 718661 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Jean-Marie Tuete
Recipient Title
Owner
JMT Inter LLC

115 Asbury Loop
Middletown, DE 19709-8655
United States

tuete@jmtinter.com
Issuing Office:
Office of Inspections and Investigations

United States

WARNING LETTER

RE: CMS# 718661

Dear Mr. Tuete:

On August 12, 2025, through September 23, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of JMT Inter LLC located at 115 Asbury Loop, Middletown, DE. FSVP inspections were also conducted by FDA from February 27 through March 20, 2023, and August 13 through August 26, 2024. This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safetymodernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on September 23, 2025.

Your significant violations of the FSVP regulation are as follows:

If requested in writing by FDA, you must send records to the Agency electronically or through another means that delivers the records promptly, rather than making the records available for review at your place of business, as required by 21 CFR 1.510(b)(3) or 21 CFR 1.512(b)(5)(ii)(c) (for Very Small Importers (VSIs)). On August 12, 2025, our Investigator provided you with a Form FDA 482d Request for FSVP Records and spoke with you by telephone on August 25, 2025, and September 9, 2025. During those conversations, you stated your firm classifies as VSI and that you would send your FSVP records. Additionally, our Investigator contacted you multiple times by email between August 12 and September 23, 2025. However, you failed to send records electronically or through another means that delivers the records promptly after receiving our request in writing. As of the date of this letter, we have not received any records from you, including documentation of VSI status or FSVP documents for soft drinks from your foreign supplier (b)(4) located in (b)(4).

During our inspection, you indicated you choose to comply with the requirements for very small importers and may meet the definition of a “very small importer” under 21 CFR 1.500. If you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of a very small importer as required per 21 CFR 1.512(b)(1)(i). You are also still required to comply with the requirements in sections 1.502, 1.503, and 1.509. However, you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (see 21 CFR 1.512(b)(3)(i)).

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States from foreign suppliers on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of your VSI status, a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Stanley Nelson, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Stanley.Nelson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Nelson via email at Stanley.Nelson@fda.hhs.gov. Please reference CMS # 718661 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Theresa Smedley
Acting Program Division Director
Division of Northeast Imports

Back to Top