FDA WARNING_LETTER - Productos Alimentios Centroamericanos, S.A. - February 12, 2012

On February 11-12, 2012, the FDA inspected Productos Alimenticios Centroamericanos S.A.'s acidified food facility in Guatemala City, Guatemala, and found serious deviations from the Acidified Foods regulation (21 CFR 114) and current Good Manufacturing Practices (21 CFR 110). The firm did not respond to the FDA-483 issued at the inspection's conclusion.

Key violations include: 1. Failure to manufacture Hot Peppers Sliced and Marinated according to the filed scheduled process, specifically using a (b)(4) instead of the required (b)(4) as a critical factor (21 CFR 114.80(a)(1)). 2. Failure to employ appropriate quality control methodology for pH determination, only testing the (b)(4) portion of the Hot Peppers Sliced and Marinated product instead of the finished (b)(4) (21 CFR 114.90(a)(6)). 3. Failure to have all processing and packaging system operators supervised by a person who attended an FDA-approved school (21 CFR 114.10). 4. Failure to provide FDA with scheduled process information for new products within 60 days of registration or before packing, continuing to export soy sauce after its submitted scheduled process was returned (21 CFR 108.25(c)(