FDA: Ineffective Cleaning, Sanitation to Blame for Lyons Magnus Contamination

The U.S. Food & Drug Administration (FDA) is pressing aseptic food and beverage maker Lyons Magnus for more answers around the company’s response to health code violations that sparked a recall of around 35 million products last summer.

In a warning letter addressed to Lyons Magnus CEO Edward Carolan, dated January 30, the agency said it had “continuing concerns” about potential health code violations at the company’s Beloit, Wisconsin manufacturing facility following multiple plant inspections and exchanges with corporate management.

According to the letter, the Fresno, California-based company initiated a voluntary recall and notified the FDA on July 26, after internal tests revealed micobiological contamination in finished products, believed to be primarily caused by ineffective cleaning and sanitation. However, the company allegedly shipped 37 batches of products (roughly 19 million units) which tested positive, none of which were reported to the agency. Additionally, no investigation into the cause of the microbial contamination was completed.

On August 10, Lyons Magnus expanded the voluntary recall alert to 53 nutritional and beverage products — around 35 million packages in total, all of which used carton packaging such as Tetra Pak or bag-in-box – including Stumptown Cold Brew, Oatly Oat Milk, Kate Farms Pediatric Standard Sole-Source Nutrition Formula and Sysco Imperial Med Plus Nutritional Shake (Vanilla), among others.

The agency wrote: “Nevertheless, these microbiological findings are concerning because the types of organisms identified could be indicators of microorganisms of public health significance, including Clostridium botulinum in the general population and Cronobacter sakazakii in pediatric populations. Cronobacter sakazakii may also be an indicator of sterility control failures since the organisms is very heat-sensitive and should not survive a validated thermal process.”

In response to a regulatory meeting in January, before the recall was issued, FDA investigators spent two weeks inspecting the Wisconsin facility in May, during which “serious violations” of healthy and safety codes were identified, according to the letter. Those included the absence of “commercial sterility… for all product contact surfaces,” specifically the aseptic tank used to process items like almond milk.

The agency returned for a second, longer inspection from August 3 through September 14, revealing three contributing factors to a decrease in cleaning efficacy: an increase in soil load, improperly cleaned tank valves and creation of bacteria in water from areas with residual build-up or plugged tubes.

According to a company response in January, Lyons Magnus has not resumed commercial operations while working with third-party consultants to review and update cleaning, maintenance, and sampling procedures for its aseptic processing and water systems. It also plans to track any future microbial recovery and to investigate the root cause for all microbial hits. Other listed actions include employee training, review and update of lab practices and procedures.

Lyons Magnus has 15 working days from the receipt of the letter to address the FDA in writing about specific steps it has taken to address any violations and provide relevant documentation.

The company is also facing a class action lawsuit that claims it used a “false, deceptive and misleading” marketing campaign during the recall that failed to list Cronobacter sakazakii on any of the 53 products’ ingredient lists.