FDA WARNING_LETTER - Appleton City Feed Service LLC - May 22, 2023

The FDA issued a Warning Letter to Ms. Smith regarding her non-FDA licensed medicated feed mill in Appleton City, MO, following an inspection from April 27 to May 22, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), requirements for animal feed containing Veterinary Feed Directive (VFD) drugs (21 CFR 558.6), and CGMP for Medicated Feeds (21 CFR Part 225). These violations cause products to be adulterated and misbranded.

Key violations include: 1. **Lack of a written food safety plan:** No hazard analysis, no preventive controls qualified individual (PCQI), and no written food safety plan, recall plan, monitoring, corrective action, or verification procedures. 2. **Failure to evaluate raw materials for mycotoxins:** No procedures or testing for mycotoxins in susceptible ingredients like corn, oats, and soybean meal. 3. **Inadequate precautions against cross-contamination:** No flushing or sequencing between batches, leading to potential carryover of toxic copper to sheep feed and contamination from unlabeled customer-provided premixes. 4. **Failure to exclude pests:** Rodent excreta, gnaw holes on feed bags, and animal tracks observed in manufacturing and storage areas. 5. **