FDA WARNING_LETTER - Manzanola Feeds, LLC - February 01, 2023

On May 11, 2023, the FDA issued a Warning Letter to Manzanola Feeds following an inspection from December 14, 2022, to February 1, 2023. The inspection was part of an investigation into a multi-state Clostridium botulinum toxicosis outbreak linked to approximately 52 equine deaths and illnesses.

Analysis of an unopened bag of "TOP OF THE ROCKIES HORSE CUBES (ALFALFA HAY IN A BAG)," lot 111422, confirmed the presence of preformed Clostridium botulinum toxin type C and animal hair, rendering the product adulterated. The firm initiated a voluntary recall on December 12, 2022, for lots 111222, 111322, 111422, 111522, and 111622.

The inspection revealed significant violations of the Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals regulations (21 CFR Part 507).

Key violations include: 1. **Failure to examine raw materials:** The firm did not adequately inspect large alfalfa hay bales for contaminants like animal carcasses, as required by 21 CFR 507.25(b)(1). The firm's response,