Bella Rosa Distribution Inc – FDA Warning Letter, Jun 22, 2021

On October 19, 2021, the FDA issued a Warning Letter to Bella Rosa Distribution, Inc. following Foreign Supplier Verification Program (FSVP) inspections on June 16, 17, and 22, 2021, and previously on March 12, 2020. 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, specifically citing Instant Drink Powder Watermelon from India, Spaghetti from Italy, and Rice from Pakistan. This violates 21 CFR 1.502(a). The company did not respond to the Form FDA 483a FSVP Observations issued on June 22, 2021.

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 Act. Bella Rosa Distribution, Inc. must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g