FDA WARNING_LETTER - Brinkman Turkey Farms Inc - February 04, 2011

On January 24 – February 4, 2011, the FDA inspected a low-acid canned food facility in Findlay, OH, manufacturing turkey/chicken broth, domesticated meats, wild game meats, and wild-caught salmon. The inspection revealed significant deviations from 21 CFR Part 113 (Low-Acid Canned Foods regulations) and 21 CFR 108 (Emergency Permit Control).

Key violations include: 1. Failure to file scheduled processes with FDA for all low-acid food products, as required by 21 CFR 108.35(c)(2). 2. Lack of heat distribution data to demonstrate adequate air venting in vertical still steam retorts, violating 21 CFR 113.40(a)(12)(iii). 3. Failure to record actual processing and production information (retort reaching processing temperature, venting time, processing time) at the time of observation, contrary to 21 CFR 113.100(a)(1). 4. Absence of scheduled processes established by qualified persons for custom-processed wild game meats (elk, deer, bear) in 401 x 411 size cans, as mandated by 21 CFR 113.83. 5. Recall procedure lacking specific methods for determining recall effectiveness, as required by 21 CFR 1