FDA WARNING_LETTER - Lyons Magnus, LLC - September 14, 2022

The FDA issued a Warning Letter to Lyons Magnus, LLC, following inspections of their aseptic processing facility in Beloit, Wisconsin, from August 3 to September 14, 2022, and May 23 to June 10, 2022. These inspections were prompted by a July 2022 recall of all low-acid canned food (LACF) products due to potential microbial contamination, including *Cronobacter sakazakii* and *Clostridium botulinum*, indicating a lack of commercial sterility.

The letter identifies serious violations of 21 CFR Part 108 (Emergency Permit Control) and 21 CFR Part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers), rendering products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Failure to promptly report microbial contamination (21 CFR 108.35(e)):** The firm delayed reporting positive lab tests for microbial contamination (Bacillus subtilis, Cronobacter sakazakii) in finished products, some of which were distributed. Internal testing records from October 2021 showed viable microorganisms in approximately 37 batches that were released without further investigation or reporting. 2. **Failure to achieve commercial sterility of equipment (21 CFR 113.40(