FDA WARNING_LETTER - Land View, Inc. - June 27, 2022
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On November 7, 2022, the FDA issued a Warning Letter to Land View, Inc. following an inspection of their medicated feed manufacturing facility in Rupert, Idaho, from June 13-17 and June 27, 2022. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulations (21 CFR Part 507), Medicated Feeds regulations (21 CFR Part 225), and Veterinary Feed Directive (VFD) requirements (21 CFR Part 558.6). These violations cause their products to be adulterated and/or misbranded.
Key violations include: 1. **Lack of a Food Safety Plan:** The firm failed to prepare and implement a written food safety plan, including hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures, as required by 21 CFR 507.31(a). 2. **Failure to Evaluate Raw Materials for Mycotoxins:** The firm did not have procedures or conduct testing for mycotoxins in incoming ingredients or finished products, violating 21 CFR 507.25(b)(2). 3. **Non-Compliance with VFD Terms:** The firm manufactured and distributed animal feed with super potent concentrations
ID · 190d5b28-ad25-4bb8-8371-bb8df3f665f0
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