FDA WARNING_LETTER - Productos Carey, Inc. - February 04, 2020

The FDA issued a Warning Letter to Productos Carey, Inc. following Foreign Supplier Verification Program (FSVP) inspections on September 18, 2018, and February 4, 2020. The inspections revealed significant violations of section 805 of the FD&C Act and 21 CFR part 1 subpart L for imported Sliced Carrots in Brine, Chipotle Peppers Whole in Adobo Sauce, Crushed Tomatillo, and Green Mexican Sauce from Productos Carey SA de CV, Mexico. Key deficiencies include the firm's failure to conduct a hazard analysis or adequately document the review and assessment of their foreign supplier's hazard analysis, as required by 21 CFR 1.504. Additionally, the company did not conduct and document foreign supplier verification activities, failing to consider applicable FDA food safety regulations (21 CFR 1.506(e)). Specifically, their SQF audit certificate did not address 21 CFR parts 117 and 113. Furthermore, for thermally processed low-acid canned foods, the firm failed to verify and document that production adhered to 21 CFR part 113, a requirement under 21 CFR 1.502(b)(1). The FDA deemed the firm's previous responses inadequate due to a lack of specific details and timeframes for corrective actions. Productos Carey, Inc. must take prompt action to correct these violations and respond within fifteen working days, providing documentation of implemented changes, such as a revised FSVP. Failure to comply may result in refusal of admission for their products under section 801(a)(3) of the FD&C Act and potential detention without physical examination (DWPE) under Import Alert # 99-41. Importation without a compliant FSVP is prohibited.