FDA Warning Letter to Pamex Foods Incorporated (May 26, 2026) — Foreign Supplier Verification Program (FSVP)

FDA Warning Letter — Violations FDA cited at Pamex Foods Incorporated

WARNING LETTER Pamex Foods Incorporated MARCS-CMS 730351 — May 26, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Javier Ramirez Recipient Title President Pamex Foods Incorporated 7900 Parston Drive District Heights , MD 20747-4426 United States Javier@pamexfood.com Issuing Office: Office of Inspections and Investigations United States WARNING LETTER Re: CMS # 730351 Dear Mr. Ramirez: On January 30 to February 10, 2026, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Pamex Foods Incorporated located at 7900 Parston Drive, District Heights, MD 20747-4426. We also conducted an inspection on November 15 to 28, 2022. These inspections were 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-safety-modernization-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 this significant violation, 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 acknowledge receipt of your response, dated February 25, 2026, in which you provided your corrective action plan (CAP). You stated that you hired (b)(4) and your firm would be in compliance within a few weeks. You also stated that you (b)(4) . FDA requested updates on your CAP on March 2, 2026, and April 1, 2026. You did not provide a response. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no FSVP documents have been received. Your significant violations of the FSVP regulations are as follows: You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods: English sauce/Worcestershire Sauce imported from (b)(4) located in the (b)(4) Frozen stuffed corn tortilla imported from (b)(4) located in (b)(4) Corn flour imported from (b)(4) located in (b)(4) 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. In addition, FDA has determined that your facility located at 7900 Parston Drive, District heights, MD 20747-4426 is subject to the food facility registration requirement in section 415 of the FD&C Act (21 U.S.C. 350d) and our implementing regulations at 21 CFR part 1, subpart H. During the most recent inspection, you were advised of this requirement. (b)(3)(A) . Failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)). As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. We request that th