FDA WARNING_LETTER - Campimex, Inc. - July 02, 2020

The FDA issued a Warning Letter following Foreign Supplier Verification Programs (FSVP) inspections conducted on June 30, 2020, and July 2, 2020, with an earlier inspection on July 10, 2018. The inspections aimed to determine compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation in 21 CFR part 1 subpart L. The firm was found not in compliance with FSVP requirements for Frozen Sliced Strawberries from manufacturer (b)(4), specifically regarding the FSVP documents presented. Additionally, for Frozen Mango Pulp, the firm lacked and failed to implement written procedures to ensure the juice was processed according to 21 CFR part 120, indicating non-compliance with 21 CFR 120.14. The FDA noted no response to the Form FDA 483a observations provided after both inspections. The firm is required to take prompt corrective action and submit a written response within fifteen working days, including documentation of revised FSVPs and implementation records. Failure to comply may lead to refusal of admission for the strawberries, detention without physical examination, and prohibition of importation under section 301(zz) of the FD&C Act.