As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Lyons Magnus LLC
Fresno, CA

A food firm in California is on notice from the FDA after an inspection of their processing facility in Wisconsin found serious violations of federal regulation. In July 2022, Lyons Magnus LLC recalled nutritional and beverage products because of potential microbial contamination, including from the organism Cronobacter sakazakii.

In a Jan. 30, 2023, warning letter, the FDA described an Aug. 3 through Sept. 14, 2022, an inspection of Lyons Magnus, LLC’s aseptic processing facility in Beloit, Wisconsin. This inspection was initiated in response to the firm’s July 2022 recall of all low-acid canned food  (LACF) products manufactured at their facility due to potential microbial contamination, including organisms Cronobacter sakazakii and Clostridium botulinum, and a lack of commercial sterility in their finished products.

The FDA’s inspection revealed that the firm was not in compliance with the Emergency Permit Control regulation and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation, resulting in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. As a commercial processor of low-acid foods packaged in hermetically sealed containers, the firm must promptly report to the FDA any instance wherin any lot of such food, which may be injurious to health by reason of contamination with microorganisms, has in whole or in part entered distribution, as required.

Specifically, on July 26, 2022, the firm notified the FDA that they initiated a voluntary recall of all products aseptically processed and packaged between (redacted), due to potential microbiological contamination in finished products, including by Bacillus subtilis and Cronobacter sakazakii. The FDA notes that Bacillus subtilis indicates a potential under-processing that could lead to contamination with Clostridium botulinum. The firm’s notification to FDA occurred (redacted) after their positive lab tests for gram-positive rods on (redacted), and (redacted) after lab testing confirmed the Bacillus subtilis result. Moreover, FDA review of their micro testing records dating back to (redacted), noted their internal microbiological tests indicated gram-positive, gram-negative rods, and cocci in approximately 37 batches of finished products that were released and shipped. These test results demonstrate the presence of viable microorganisms in their commercial products, the majority of which they had not previously reported to FDA. The firm did not conduct additional testing of these batches to speciate or identify organisms. On Aug. 10, 2022, they voluntarily expanded their recall for all products produced since (recalled), due to potential microbiological contamination.

Some of the affected products in their voluntary recall include, but are not limited to:

• Glucerna Chocolate 24ct 8oz Club: Batch (redacted); manufactured on (redacted); shipped on (redacted). This lot tested positive for gram-positive rods.
• Redcon1 MRE Protein Shake Milk Chocolate: Batch (redacted); manufactured on (redacted); shipped on (redacted). This lot tested positive for gram-positive rods.
• Kate Farms Pediatric Standard Sole-Source Nutrition Formula 1.2 cal/mL: Batches (redacted) and (redacted); both manufactured on (redacted); both shipped on (redacted). Both batches tested positive for gram-negative rods.
• Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink: Batch (redacted) manufactured on (redacted); shipped on (redacted). This lot tested positive for gram-positive rods.

The firm recalled approximately 35 million packages; approximately 19 million had been shipped and needed to be recalled from customers.

The FDA reminded the firm that their aseptically packaged products containing viable microorganisms do not meet the definition of commercial sterility, and are, therefore, adulterated. Shipping adulterated products into interstate commerce is prohibited. The firm must promptly alert FDA of lots shipped with known microbial contamination, not just those lots with confirmed species as identified in July 2022. Additionally, the firm shipped these products without conducting a full investigation into the cause of the microbial contamination. They indicated in their Oct. 5, 2022, response that micro findings prior to April 2022 were attributed to laboratory error, yet they did not conduct an assessment of their laboratory practices prior to April 2022. Microbial findings in finished product indicate a loss of sterility during production of that batch and warrant further investigation. 

2. Before the start of aseptic processing operations, the product sterilizer and all product-contact surfaces (redacted) shall be brought to a condition of commercial sterility as required, wher commercial sterility of equipment and containers used for aseptic processing and packaging of food means the condition achieved by application of heat, chemical sterilant(s), or other appropriate treatment that renders the equipment and containers free of viable microorganisms having public health significance, as well as microorganisms of non-health significance, capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution.

Specifically, on (redacted), they initiated a “(redacted)” to “(redacted)” production at the facility by increasing volume of products run through each processor between (redacted). Processors (redacted) increased from (redacted) gallons to (redacted) gallons; Processor (redacted) was supposed to remain at (redacted) gallons between (redacted). The firm informed process operators of these changes; however, the changes were not built into their programming, and they did not updat their (redacted) or Clean-in-Place (CIP) procedures to accommodate this change. (Redacted) were not routinely monitored or tracked, and their chemical supplier was not contacted prior to initiating the (redacted) to ensure established cleaning procedures would be adequate.

The firm’s finished product testing found microbiological contamination in products manufactured on (redacted), on all (redacted) processors, including, but not limited to the products listed in the table below:

All the products listed in the above table were released into commercial distribution and subsequently recalled by the firm. 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. The firm did not perform any speciation of finished product microbiological findings until July 2022, when they identified Cronobacter sakazakii in product manufactured on (redacted); however, this product was not distributed.

Although they were aware of the April 2022 microbiological contamination, their firm did not stop processing until July 15, 2022, and began an internal investigation on July 16, 2022. The firm’s investigation determined that process operators ran Processor (redacted) for (redacted) gallons before conducting an (redacted), not (redacted) gallons as instructed. They also disassembled the processors and inspected with a (redacted). Their technicians reported finding a portion of the (redacted) in the (redacted) and heating sections of Processor (redacted) partially blocked with residual product, the (redacted) on Processor (redacted) were partially blocked, there was visible residue in the (redacted) of Processor (redacted), and there was what appeared to be a dried residual “film” at the (redacted) flow panel at valve ((redacted)). This was not the first time in 2022 wher their firm had identified product fouling in Processor (redacted) after the minimum wash flow rates could not be reached during CIP, as their firm identified events on Feb. 13, and April 6, 2022 (though they reported that no blockage was found after they successfully completed their CIP).

As part of their investigation, they conducted environmental testing which found microbial contamination (redacted) of the (redacted) process) at Aseptic Tank (redacted) valve ((redacted)), Processor (redacted) valve ((redacrted)), and (redacted) valve ((redacted)) for Aseptic Tank (redacted) which connects to Fillers (redacted), and (redacted); and (redacted) in their (redacted) System. In July 2022, (redacted) water in (redacted) tested positive for Cronobacter sakazakii. A review of their (redacted) water testing from Oct. 2021 through May 2022 found positive single plate count (SPC) microbiological results in both (redacted) and (redacted). The (redacted) water is used for batching as an ingredient, during non-sterile CIP cleaning in the processors, for (redacted) water (redacted) during processing in the processors, and in the sterile (b)(4) rinse step after the processors are (redacted) cleaned. As mentioned previously, they also identified Cronobacter sakazakii in finished product manufactured on (redacted). The firm’s third-party laboratory analyzed the isolates of Cronobacter sakazakii found in their (redacted) water and finished product and found the isolates were a genetic match, which could indicate a failure of their thermal process or post-thermal process contamination.

This is a repeat observation from the FDA inspection conducted May 23 to June 10, 2022, wher the FDA observed that a condition of commercial sterility was not achieved for all product contact surfaces (redacted) from the product sterilizer before starting aseptic processing operations, as required. Specifically, Aseptic Tank (redacted), which feeds Line (redacted) aseptic filler required the addition of (redacted) and (redacted) to the sterilization procedure to ensure all areas of the aseptic tank meet commercial sterility, as established by their external Process Authority (PA). Prior to May 26, 2022, their Aseptic Tank (redacted) was not programmed to achieve these parameters and they did not meet the requirements. For example, on (redacted), they processed Lyons Barista Almond Milk, Item 10165, coded 5012-03. The tank sterilization chart shown as (redacted), Chart #(redacted), shows a sterilization procedure starting at approximately (redacted) and lasting until (redacted), which is at least (redacted) short of the time required for this system. The firm’s response dated June 20, 2022, discusses correction of their system set points to match the PA validation and assessed potentially affected product. They state, “All commercial sterility tests: incubated micro and pH have all passed….” However, as discussed in this letter, they were aware of microbial findings in finished product, including Item 10165, Lyons Barista Style Almond Milk, produced on (redacted), lot 5012-03, at five different timestamps, which resulted in the discard of 1,716 cases of product.

The firm’s Root Cause Analysis provided to us at the close of the Aug. 3 to Sept. 14, 2022, inspection identified three factors contributing to the decrease in the effectiveness of the cleaning process: (1) variations in product matrices and production intervals likely led to an increase in soil load and a decrease in cleaning efficacy; (2) (redacted) tank valves were not properly cleaned due to coding errors in their (redacted) system; and (3) bacteria in their (redacted) water was likely able to “seed” the system in areas wher there was residual build-up or plugged tubes. The FDA notes the (redacted) water was, by design, used to flush the system while the processor was in a non-sterile state during cleaning.

The full warning letter can be viewed here.