FDA WARNING_LETTER - Pancrazio S.P.A. - October 31, 2013

On April 18, 2014, the FDA issued a Warning Letter to Pancrazio S.P.A. following an inspection of their low-acid canned food (LACF) facility in Cava Dei Tirreni, Italy, on October 30-31, 2013. The inspection revealed serious deviations from the Emergency Permit Control regulation (21 CFR 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113).

Key violations included: 1. **Failure to substantiate changes to scheduled processes (21 CFR 108.35(c)(2)(ii)):** After replacing retorts in May 2012, the firm did not conduct new heat penetration and heat distribution studies or establish new processes for products like Chick Beans, Kidney Beans, and Lentils. 2. **Failure to file scheduled processes (21 CFR 108.35(c)(2)):** No scheduled process was filed for Mixed Beans in 400-gram cans. 3. **Failure to process in conformity with scheduled process (21 CFR 108.35(c)(3)(i)):** Process records for Chick Beans showed a shorter sterilization time than the filed scheduled process. 4. **Failure to accurately determine and record initial temperature (21 CFR