Lyons Magnus, LLC

Warning LetterOpen

Edward Carolan Chief Executive Officer Lyons Magnus, LLC 3158 E. Hamilton Avenue Fresno , CA 93702-4163 United StatesFEI 2938745Issued Jan 30, 2023Division of Human and Animal Food Operations West I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2938745.

Violations8

Issue DateJan 30, 2023

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Lyons Magnus, LLC
Location: Edward Carolan Chief Executive Officer Lyons Magnus, LLC 3158 E. Hamilton Avenue Fresno , CA 93702-4163 United States
FEI Number: 2938745
Country: United States
Issue Date: January 30, 2023
Issuing Office: Division of Human and Animal Food Operations West I
Product Type: Food & Beverages
Status: Open

Summary

Lyons Magnus, LLC was warned about serious violations in its manufacture of low-acid canned food (LACF) beverages at its aseptic processing facility in Beloit, Wisconsin, following a July 2022 recall due to potential microbial contamination including Cronobacter sakazakii and Clostridium botulinum. The FDA identified violations of the Emergency Permit Control regulation (21 CFR Part 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113), rendering the products adulterated. The violations were discovered during inspections conducted in May-June 2022 and August-September 2022, with the latter inspection directly triggered by the company's own product recall due to lack of commercial sterility in finished products.

Lyons Magnus, LLC FDA Warning Letter, January 30, 2023