FDA WARNING_LETTER - Premier Food Supplies LLC - March 23, 2023

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Premier Food Supplies LLC from March 14-23, 2023, to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L. The inspection revealed significant violations for foods imported from various foreign suppliers, including Boondi Plain (Boondi Salted) and Nimbu Masala from Haldiram Snacks Pvt. Ltd., and Cut Mango Pickle with Garlic. Specifically, the firm failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). They also did not conduct or adequately document a written hazard analysis for each imported food, including documenting review and assessment by a qualified individual, as per 21 CFR 1.504. Furthermore, Premier Food Supplies LLC failed to evaluate foreign supplier performance and food risk, and document supplier approval (21 CFR 1.505(a) and (b)). Lastly, the firm did not perform or document required foreign supplier verification activities, including determining appropriate activities and their frequency (21 CFR 1.506). The company's April 10, 2023, response with general SOPs was deemed insufficient as it lacked specific documentation for the identified foods and suppliers. Premier Food Supplies LLC must respond within fifteen working days with detailed corrective actions and supporting documentation. Failure to comply may result in refusal of admission, detention without physical examination, and prohibition of importation.