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  5. HolleHippos LLC - 640447 - 10/18/2022
  1. Warning Letters

WARNING LETTER

HolleHippos LLC MARCS-CMS 640447 —

Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Elena P. Sytsma
Recipient Title
Owner
HolleHippos LLC

100 Waterford Dr
Thibodaux, LA 70301-8013
United States

Issuing Office:
Division of Southeast Imports

United States

October 18, 2022

WARNING LETTER

Re: CMS # 640447

Dear Ms. Elena P. Sytsma:

On June 14 to June 16, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of HolleHippos LLC, located at 100 Waterford Dr, Thibodaux, LA 70301. This inspection was 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 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 acknowledge receipt of your email response dated July 5, 2022, and we address your response below. In your response, you stated your intent to “take a course” in the immediate term to develop and maintain an FSVP for your firm and to request “all the food safety documents” from one of your suppliers; you characterized these activities as your corrective action plan. We are unable to evaluate the adequacy of your response because you have not provided any supporting documents, described specific steps you have taken to comply with the FSVP regulation for all foods you import, or updated us on the implementation of the activities you characterized as your corrective action plan.

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, you did not develop, maintain, and follow an FSVP for any of the food products that you import, including:

  • Kendamil Organic Milk imported from Kendal Nutricare Ltd, located in the United Kingdom.
  • Hipp Organic Infant Formula imported from Hipp GmbH & CO, located in Germany.

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 with the 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 foods 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 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 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: Ms. Ruth Dixon, Program Division Director, Division of Southeast Imports, 404 BNA Drive, Building 200 - Suite 500 Nashville, TN 37217-2565. If you have any questions regarding this letter, you may contact Ms. Coral del Mar Lopez, Compliance Officer via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS # 640447 on any documents or records you provide to us and in the subject line of any email correspondence you send to us.

Sincerely,
/S/

Ruth Dixon
Program Division Director
Division of Southeast Imports

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