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  5. Cavevi Naturals LLC - 666694 - 11/08/2023
  1. Warning Letters

WARNING LETTER

Cavevi Naturals LLC MARCS-CMS 666694 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Maria Cantu
Recipient Title
Owner
Cavevi Naturals LLC

13602 Paxton Blvd
St. Hedwig, TX 78152
United States

Issuing Office:
Division of Southwest Imports

United States

Secondary Issuing Offices

United States

November 08, 2023

WARNING LETTER

Re: CMS # 666694

Dear Ms. Cantu,

On August 4, 2023 through August 9, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Cavevi Naturals LLC., located at 25104 Brushline Rd., Edinburg, TX 78542-3451. We also conducted an inspection on December 16, 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-foreignsupplier-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 with Form FDA 483a, FSVP Observations.

We acknowledge receipt of your written response dated August 31, 2023. In your response, you stated you are looking to hire a consultant to develop your FSVP which would take four months to complete. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation regarding your implementation of an FSVP or copies of your FSVPs.

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 of the foods you import, including:

  • (b)(4) candy imported from (b)(4), located in (b)(4)
  • (b)(4) candy imported from (b)(4), located in (b)(4)
  • Cheetos Nacho 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.

Please send your reply to the Food and Drug Administration, Attention: Ernesto Barba, Compliance Officer, Division of Southwest Imports, 9725 Via de la Amistad, Ste 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Compliance Officer Ernesto Barba via email at Ernesto.Barba@fda.hhs.gov. Please reference CMS # 666694 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
Director
Division of Southwest Imports
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202


Cc:
Cavevi Naturals Llc
13602 Paxton Blvd.
St. Hedwig, TX 78152

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