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WARNING LETTER

Promex Distribution LLC MARCS-CMS 605677 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Omar Salazar Cavazos
Recipient Title
Owner
Promex Distribution LLC

200 S. Main St., Ste. 689
McAllen, TX 78503-5524
United States

Issuing Office:
Division of Southeast Imports

United States


April 13, 2020

WARNING LETTER


Re: CMS # 605677

Dear Mr. Omar Salazar Cavazos:

On August 23, 2018, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Promex Distribution, LLC, 901 E. Produce Rd, Hidalgo, TX 78557. We also conducted an inspection on February 11, 2020. 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 your carbonated mineral water and cornmeal, both from foreign supplier (b)(4).

Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial FSVP inspection on August 23, 2018, and the follow-up inspection on February 11, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We have not received your response to either Form FDA 483a.

Your significant violations of the FSVP regulation 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 part 1 subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:

• Carbonated mineral water manufactured by (b)(4) and imported under entry (b)(4)

• Cornmeal manufactured by (b)(4) and imported under entry (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.

You should take prompt action to correct the above violations. If you do not promptly correct them, 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 carbonated mineral water manufactured by (b)(4) and cornmeal manufactured by (b)(4), as well as other foods you import and for which you have not developed and implemented FSVPs. We may place these foods on detention without physical examination (DWPE) when you import the products. 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.

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 these 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 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: Celina C. Guardiola, Compliance Officer, US FDA, 216 W. Village Blvd., Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, you may contact CO Guardiola via email at Celina.Guardiola@fda.hhs.gov. Please reference CMS # 605677 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
District Director
Division of Southwest Imports

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