FDA WARNING_LETTER - Dairy Feeds, Inc. - December 20, 2021

The FDA inspected a non-licensed medicated and non-medicated feed mill in Okeechobee, Florida, producing feeds for beef and dairy cattle, on December 13, 14, and 20, 2021. The inspection revealed significant violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507), requirements for animal feed containing a Veterinary Feed Directive (VFD) drug (21 CFR 558.6), and Medicated Feed CGMP (21 CFR Part 225), rendering products adulterated or misbranded. Key violations included the failure to prepare and implement a food safety plan (21 CFR 507.31(a)), distribute VFD feed with non-conforming or missing cautionary labeling (21 CFR 558.6(c)(2)), properly handle and store medicated feed labels to prevent mix-ups (21 CFR 225.180), and evaluate raw materials susceptible to mycotoxin contamination (21 CFR 507.25(b)(2)). The firm's January 12, 2022, response was deemed inadequate due to insufficient detail or supporting evidence. The FDA requires a written response within fifteen working days detailing corrective actions and supporting documentation to prevent legal action, including seizure and injunction.