FDA WARNING_LETTER - VISVITA CORPORATION - April 26, 2022

On August 23, 2022, the FDA issued a Warning Letter to Visvita Corporation following a Foreign Supplier Verification Program (FSVP) inspection on April 26, 2022, and previous inspections on July 16-17, 2019. The inspection found the company non-compliant 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 foods, as required by 21 CFR 1.502(a). The company's April 26, 2022, response, stating they retained a third-party consulting firm and expected compliance within 60 days, was deemed inadequate due to a lack of supporting documentation or specific actions taken.

Failure to 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 placement on detention without physical examination (DWPE) via Import Alert #99-41. The importation of food without a compliant FSVP is also prohibited under section 301(zz) of the FD&C Act.

Visvita Corporation must respond in writing within fifteen working days, detailing corrective