WARNING LETTER
Pamex Foods Incorporated
MARCS-CMS 730351 —
May 26, 2026
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
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and your firm would be in compliance within a few weeks. You also stated that you
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. 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
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located in the
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Frozen stuffed corn tortilla imported from
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located in
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Corn flour imported from
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located in
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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 the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
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 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 changes you made, such as 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: Feryal Ahmad, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy)
Feryal.Ahmad@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ahmad via email at Feryal.Ahmad@fda.hhs.gov. Please reference CMS # 730351 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
CDR Joseph S. Tomao
Program Division Director
Division of Northeast Imports
Content current as of:
06/23/2026
Regulated Product(s)
Food & Beverages