FDA WARNING_LETTER - Furst-McNess Company - August 28, 2023

The FDA issued a Warning Letter to a non-FDA licensed medicated animal food manufacturing facility in Lodi, Wisconsin, following an August 23-28, 2023, inspection. The inspection was prompted by a Reportable Food Registry report concerning multiple goat illnesses and deaths linked to medicated goat feed (Product B9251, 18% Goat Starter, lot 071423) containing excessive monensin, which the facility voluntarily recalled on August 21, 2023.

The FDA found the goat feed adulterated due to a super-potent concentration of monensin, not conforming to drug approval, and significant violations of Current Good Manufacturing Practice (CGMP) for Medicated Feeds (21 CFR Part 225) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507).

Specifically, the facility failed to implement an adequate preventive control for "high medication in feed." Their identified "Process Control" involving a second sign-off was deemed insufficient, as demonstrated by an employee adding significantly more monensin than required to a batch, resulting in a concentration over 10 times the labeled amount. This super-potent feed was distributed, causing goat illnesses and deaths. The facility's investigation into the error was also found to be inadequate.

Furthermore, the facility lacked adequate procedures for identification, storage, and inventory control of medicated articles