PROVITUS Dabrowscy, Malesa S.J. – FDA Warning Letter, Jan 31, 2014

The FDA inspected Provitus Dabrowscy, Malesa S.J. in Zambrow, Poland, on January 30-31, 2014, and found serious deviations from regulations for acidified and low-acid canned foods (LACF) (21 CFR 108 and 21 CFR 113), and food labeling (21 CFR 101). The firm did not respond to the FDA-483 issued at the inspection's conclusion.

Key violations include: 1. **Food Adulteration:** * Failure to file scheduled processes with FDA for LACF products like "Sautéed Carrots" and "Sautéed Wild Mushrooms – Suillus Luteus," violating 21 CFR 108.35(c)(2). * Inability to provide process and procedure information demonstrating adequate heat distribution for products processed in horizontal still sterilizers, violating 21 CFR 108.35(c)(3)(ii). The firm relied on "years of experience" and had not provided status/results of a promised heat distribution/penetration study. * Failure to ensure retorts had accurate, functional temperature-recording devices (21 CFR 113.40(a)(2)). * Failure to equip retorts with automatic steam controllers (21 CFR 113.4