Knight Feedlot Inc – FDA Warning Letter, Jan 4, 2011
An FDA inspection of Knight Feedlot Inc.'s medicated feed mill from December 2010 to January 2011 revealed significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (21 CFR 225), rendering their feeds adulterated.
Key violations include: 1. **Failure to investigate and take corrective action on out-of-limits assay reports (21 CFR 225.58(d))**: For example, two medicated feed assays (monensin and melengestrol acetate) were out of permissible limits, with no documented investigation or corrective action. 2. **Failure to maintain complete daily drug inventory records (21 CFR 225.42(b)(6)(i))**: Drugs in bins without load cells (e.g., Zilpaterol hydrochloride, Ractopamine) were not counted. Multiple examples of incorrect or missing lot numbers in daily drug use records were found. 3. **Failure to properly identify, store, handle, and control drugs (21 CFR 225.42(b)(4))**: A bag of Tylan 100 lacked lot code and expiration date after opening. 4. **Failure to maintain a complete and accurate Master Record File (21 CFR 225.102(b)(1))**.
The FDA clarified that all medicated
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