FDA WARNING_LETTER - Conservas La Torre S.A. de C.V. - August 19, 2011

The FDA inspected Conservas La Torre S.A. de C.V.'s acidified foods facility in Mexico on August 18-19, 2011, and issued an FDA-483 for serious deviations from 21 CFR Part 114 (acidified food regulation) and 21 CFR Part 108 (emergency permit control regulation). The firm did not respond to the FDA-483.

Significant violations include: 1. Failure to record deviations from the filed scheduled process in a separate log, as required by 21 CFR 114.89. Examples cited include manufacturing "Rodajas de Jalapeno" and "Rajas de Jalapeno" with processing temperatures and thermal processes that deviated from the scheduled 212°F. 2. Failure to have personnel involved in acidification, pH control, heat treatment, and critical factors under the operating supervision of a person who has completed an FDA-approved school, as required by 21 CFR 108.25(f).

These failures render the products adulterated under Section 402(a)(4) of the Act and constitute a basis for immediate application of emergency permit control provisions, including refusal of admission and detention without physical examination (DWPE) under Section 801(a) of the Act, potentially leading to an Import Alert like #99-04.

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