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WARNING LETTER

Mercado Hispano Distributors, LLC MARCS-CMS 634708 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Jesus Rojas
Recipient Title
Owner
Mercado Hispano Distributors, LLC

4747 Granite Drive Suite B
Tucker, GA 30084
United States

Issuing Office:
Division of Southeast Imports

United States


August 2, 2022

WARNING LETTER

CMS # 634708

Dear Mr. Rojas:

On February 23 through March 23, 2022, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Mercado Hispano Distributors, LLC located at 4747 Granite Drive Suite B, Tucker, GA 30084. We also conducted an initial inspection on March 22, 2018, and a follow-up inspection on November 3 through December 18, 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 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 in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response to the Form FDA 483a on May 9, 2022, in which you provided confirmation of registration for an online FSVP training. However, we note this is the third inspection in which you did not have any FSVP records. Furthermore, you did not provide any documentation of the activities you are taking in order to comply with the FD&C Act.

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 1.502(a). Specifically, your firm did not develop an FSVP for any of the foods you import, including each of the following:

  • (b)(4) Cola and (b)(4) Manzana imported from (b)(4), located in (b)(4)
  • (b)(4) Grapefruit 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 compliant 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, the FDA may act 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 which 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.

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., 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 your products 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: Jason Ferry, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Road, Ste. 100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Ferry via email at jason.ferry@fda.hhs.gov. Please reference CMS case #634708 and work activity #454107 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/

Chris Boulmay
Acting Program Division
Director Division of
Southeast Imports

 
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