VERO USA CORPORATION – FDA Warning Letter, Jul 7, 2022

On September 26, 2022, the FDA issued a Warning Letter to Vero USA Corporation following Foreign Supplier Verification Program (FSVP) inspections conducted on May 25, June 8, and July 7, 2022, and previously from May 14-25, 2021. The inspections determined non-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 foods, as required by 21 CFR 1.502(a). This deficiency was noted for all imported foods. The firm received a Form FDA 483a FSVP Observations, which was amended on July 7, 2022. Although the firm indicated hiring a third party and requested an extension, no further response was received by the FDA after granting an extension until July 29, 2022.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C