HolleHippos LLC – FDA Warning Letter, Jun 16, 2022

On June 14-16, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of HolleHippos LLC, located at 100 Waterford Dr, Thibodaux, LA 70301. The inspection determined the company was not in compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1, subpart L).

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported food products, as required by 21 CFR 1.502(a). The FDA issued a Form FDA 483a, FSVP Observations, at the inspection's conclusion.

HolleHippos LLC's email response dated July 5, 2022, stating intent to "take a course" and request "all the food safety documents" from a supplier, was deemed inadequate. The response lacked supporting documentation, specific steps for compliance across all imported foods, or updates on the proposed corrective actions.

Failure to adequately address these violations may result in further FDA action, including refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert # 99-41. Importing food without a compliant