TriOak Foods Inc – FDA Warning Letter, Jan 15, 2015

The FDA and Illinois Department of Agriculture inspected TriOak Foods, Inc.'s medicated feed mill in Bushnell, IL, from January 13-15, 2015. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for licensed medicated feed manufacturers (21 CFR Part 225), rendering their medicated feed adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Violations include: 1. **Lack of Master Record File (21 CFR 225.102(b)(1))**: The firm's SOPs lacked required information (drug/non-drug ingredients, label copy, manufacturing instructions, control directions, sampling frequency) and were not properly prepared, checked, dated, or signed. 2. **Failure to Perform Required Assays (21 CFR 225.58(b)(1))**: For Category II Type A Medicated Articles, the firm failed to collect at least three representative samples for assay at periodic intervals during 2014 for multiple drug combinations. 3. **Failure to Investigate Out-of-Limits Assays and Implement Corrective Actions (21 CFR 225.58(d))**: An assay for a Category II Type A medicated article on August 13, 2014, showed