FDA WARNING_LETTER - Nestle Purina PetCare - October 01, 2014

The FDA issued a Warning Letter to Nestle Purina PetCare's Allentown, PA facility following an inspection from September 15 to October 1, 2014, which revealed significant deviations from low-acid canned food (LACF) regulations (21 CFR Parts 108 and 113).

Violations included: 1. **Failure to process in conformity with the scheduled process (21 CFR 108.35(c)(3)(i)):** * Alpo Chop House Rotisserie Chicken flavor: A lot was processed with a shorter cook time than required for its initial temperature. * FCC Mariner’s Catch and FCC Mixed Grill: Retort temperature charts showed critical factor deviations (in-feed leg temperature drops) not documented on daily process records. * Friskies Gravy Sensations: Pouches were observed entering the retort stacked, exceeding the critical factor for pouch thickness, and pouch thickness was not monitored or documented. This was a repeat observation from a 2007 inspection. 2. **Failure to identify and log process deviations (21 CFR 113.89):** Deviations from scheduled processes and critical factors were not identified or recorded in a separate log detailing actions taken. 3. **Failure to sanitize cooling water (21 CFR 113.60(b)):** Cooling cushion water in the retort