FDA 483 - Bella Rosa Distribution Inc - March 10, 2022

An FDA inspection of Bella Rosa Distribution Inc in Minneapolis revealed significant and repeat violations related to its Foreign Supplier Verification Program (FSVP). The firm failed to develop an FSVP for imported foods, lacked a written hazard analysis for specific products, and did not establish proper procedures for foreign supplier evaluation, approval, and verification activities. Additionally, the firm did not ensure a qualified individual developed its FSVP and had issues with electronic filing information with U.S. Customs and Border Protection.