FDA WARNING_LETTER - Vietti Acquisitions, LLC - July 14, 2014

The FDA inspected Zwanenberg Food Group (USA) Inc.'s low-acid canned food (LACF) facility, Vietti Acquisitions, from July 7-10 and 14, 2014. The inspection revealed significant deviations from 21 CFR 108 (Emergency Permit Control), 21 CFR 113 (LACF), and 21 CFR 110 (CGMP).

Violations included: - **LACF Violations:** Failure to submit revised scheduled processes for hot dog chili sauce after changing retort types (21 CFR 108.35(c)(2)(ii)). Failure to test thermometers for accuracy annually; the standard thermometer had not been calibrated since July 2012 (21 CFR 113.40(a)(1)). Concerns were raised about using a computer-based program to calculate infinite process times based on varying Minimum Initial Temperatures (MITs) without a standardized MIT measurement methodology. - **GMP Violations:** Improper thawing of frozen raw materials, with temperatures observed at 53°F in the staging cooler and 85°F for green chilies in the kitchen area (21 CFR 110.80(a)(6)). Facility construction issues, including excessive condensate dripping onto products and dirty standing water in the cooler (21 CFR 110.20(b)(4)). Failure to clean