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  5. Alymar LLC - 626418 - 04/12/2022
  1. Warning Letters

WARNING LETTER

Alymar LLC MARCS-CMS 626418 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Josue Marroquin
Recipient Title
Owner
Alymar LLC

527 Wild Wind Ln
Houston, TX 77013-5523
United States

Issuing Office:
Southwest Imports

United States

April 12, 2022

WARNING LETTER

Re: CMS # 626418

Dear Mr. Marroquin:

On January 3 and 11, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Alymar LLC located at 527 Wild Wind Ln, Houston, Texas, 77013-5523. We also conducted an inspection on January 13, 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-supplierverification-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 January 11, 2022.

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

  • Cola soft drinks imported from (b)(4), located in (b)(4)
  • Potato chips imported from (b)(4), located in (b)(4)
  • Corn chips 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.

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.

Additionally, we note that (b)(3)(A). You discussed during the inspection that your firm receives and distributes the food from your foreign suppliers at a warehouse you operate located in (b)(4). 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 (b)(3)(A).

(b)(3)(A)

Please send your reply to Food and Drug Administration, Attention: Lisa Puttonen, Compliance Officer, Division of Southwest Imports, One Main Place, 1201 Main St, Suite 7200, Dallas, Texas 75202. If you have any questions regarding this letter, you may contact Lisa Puttonen via email at lisa.puttonen@fda.hhs.gov. Please reference CMS # 626418 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
Director, Southwest Imports

 
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