FDA WARNING_LETTER - Productos del Convento, S.A. de C.V. - August 23, 2011

On February 6, 2012, the FDA issued a Warning Letter to Productos del Convento, S.A. de C.V. following an inspection of their low-acid canned foods facility in Mexico City on August 22-23, 2011. The inspection revealed serious deviations from 21 CFR Part 113 (Low-Acid Canned Foods) and 21 CFR Part 108 (Emergency Permit Control). The firm failed to respond to the FDA-483 issued at the inspection's conclusion.

Key violations for their "Chongos Zamoranos" product included: 1. Processing not conforming to the scheduled process (e.g., product received a (b)(4) instead of the scheduled (b)(4)). 2. Process timing beginning before proper retort venting and temperature were reached (e.g., products retorted without reaching (b)(4)). 3. Failure to determine and record initial product temperatures with sufficient frequency. 4. Failure to identify and record deviations from the filed scheduled process or critical factors. 5. Failure to post operating processes for each product and container size conspicuously near processing equipment.

These violations render the products adulterated under Section 402(a)(4) of the Act. The FDA may refuse admission of the firm's products under Section 801 of the Act, including detention without physical