FDA WARNING_LETTER - Procesamiento Especializado De Alimentos S.A.P.I. De C.V. - April 06, 2015

On August 12, 2015, the FDA issued a Warning Letter to Procesamiento Especializado De Alimentos S.A.P.I. De C.V. following an inspection from April 4-6, 2015. The inspection revealed serious deviations from regulations for Emergency Permit Control (21 CFR 108), Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113), and seafood Hazard Analysis and Critical Control Point (HACCP) (21 CFR 123).

Key violations include: * **LACF Deviations:** Failure to chlorinate container cooling water (21 CFR 113.60(b)), failure to record observations of visual closure examinations (21 CFR 113.60(a)), and inadequate examination of pouch container closures (21 CFR 113.60(a)(3)). The firm's response regarding these issues was deemed insufficient due to lack of implementation evidence. * **Seafood HACCP Deviations:** The firm's HACCP plan for pouched tuna was inadequate. It failed to identify and control hazards like *Staphylococcus aureus* growth and toxin formation due to prolonged unrefrigerated exposure, and allergens (tuna and soy) requiring proper declaration on labels (21 CFR 123.6(a), (c)(1)).