Lyons Magnus, LLC MARCS-CMS 645766 — January 30, 2023

WARNING LETTER

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• Delivery Method: VIA UPS
• Product: Food & Beverages

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• Recipient: Edward Carolan; Chief Executive Officer; Lyons Magnus, LLC; 3158 E. Hamilton Avenue; Fresno, CA 93702-4163; United States

• Issuing Office: Division of Human and Animal Food Operations West I; United States

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January 30, 2023

WARNING LETTER

Refer to CMS 645766

Dear Mr. Carolan:

The U.S. Food and Drug Administration (FDA) inspected your aseptic processing facility where your firm manufactures a variety of ready-to-eat (RTE) aseptically packaged low-acid canned food (LACF) beverages packaged in hermetically sealed containers, located at 2924 Wyetta Drive, Beloit, Wisconsin, on August 3 to September 14, 2022. This inspection was initiated in response to your July 2022 recall of all LACF products manufactured at your facility due to potential microbial contamination, including organisms Cronobacter sakazakii and Clostridium botulinum, i.e., lack of commercial sterility in your finished products. Further, FDA inspected your facility on May 23 to June 10, 2022, in response to a Regulatory Meeting held with your firm on January 6, 2022. During both inspections we identified serious violations of the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108)) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR Part 113). At the conclusion of each of these inspections the FDA investigators issued a Form FDA-483, Inspectional Observations (FDA-483), that lists the serious violations observed at the firm. Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR Part 113 renders your low-acid products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).

We reviewed your written responses dated October 5, 26, November 7, 14, 18, December 2 and 9, 2022, and January 23, 2023, which describe your completed and planned corrective actions and your plant recommissioning plan. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this Warning Letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

Your significant violations are:

1. As a commercial processor of low-acid foods packaged in hermetically sealed containers, you must promptly report to the FDA any instance wherein 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 by 21 CFR 108.35(e).

Specifically, on July 26, 2022, you notified FDA that you initiated a voluntary recall of all products aseptically processed and packaged between (b)(4), due to potential microbiological contamination in finished products, including by Bacillus subtilis and Cronobacter sakazakii. We note that Bacillus subtilis indicates a potential under-processing that could lead to contamination with Clostridium botulinum. Your notification to FDA occurred (b)(4) after your positive lab tests for gram-positive rods on (b)(4), and (b)(4) after lab testing confirmed the Bacillus subtilis result. Moreover, our review of your micro testing records dating back to (b)(4), noted your internal microbiological tests indicated gram-positive, gram-negative rods, and cocci in approximately 37 batches of finished products which were released and shipped. These test results demonstrate the presence of viable microorganisms in your commercial products, the majority of which you had not previously reported to FDA. You did not conduct additional testing of these batches to speciate or identify organisms. On August 10, 2022, you voluntarily expanded your recall for all products produced since (b)(4), due to potential microbiological contamination.

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

• Glucerna Chocolate 24ct 8oz Club: Batch (b)(4); manufactured on (b)(4); shipped on (b)(4). This lot tested positive for gram-positive rods.
• Redcon1 MRE Protein Shake Milk Chocolate: Batch (b)(4); manufactured on (b)(4); shipped on (b)(4). This lot tested positive for gram-positive rods.
• Kate Farms Pediatric Standard Sole-Source Nutrition Formula 1.2 cal/mL: Batches (b)(4) and (b)(4); both manufactured on (b)(4); both shipped on (b)(4). Both batches tested positive for gram-negative rods.
• Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink: Batch (b)(4) manufactured on (b)(4); shipped on (b)(4). This lot tested positive for gram-positive rods.

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

We remind you that your aseptically packaged products containing viable microorganisms do not meet the definition of commercial sterility, per 21 CFR 113.3(e)(1)(i)(a) and are, therefore, adulterated. Shipping adulterated products into interstate commerce is a prohibited act under section 301(a) of the Act. Under 21 CFR 108.35(e) your 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, you shipped these products without conducting a full investigation into the cause of the microbial contamination. You indicated in your October 5, 2022, response that micro findings prior to April 2022 were attributed to laboratory error, yet you did not conduct an assessment of your 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. Per 21 CFR 113.40(g)(2)(ii)(B), “[i]n the event of loss of sterility, the system(s) shall be returned to a condition of commercial sterility before resuming packaging operations.”

2. Before the start of aseptic processing operations, the product sterilizer and all product-contact surfaces (b)(4) shall be brought to a condition of commercial sterility as required by 21 CFR 113.40(g)(1)(ii)(A), where 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, as defined in 21 CFR 113.3(e)(2).

Specifically, on (b)(4), you initiated a “(b)(4)” to “(b)(4)” production at the facility by increasing volume of products run through each processor between (b)(4). Processors (b)(4) increased from (b)(4) gallons to (b)(4) gallons; Processor (b)(4) was supposed to remain at (b)(4) gallons between (b)(4). You informed process operators of these changes; however, the changes were not built into your programming, and you did not update your (b)(4) or Clean-in-Place (CIP) procedures to accommodate this change. (b)(4) were not routinely monitored or tracked, and your chemical supplier was not contacted prior to initiating the (b)(4) to ensure established cleaning procedures would be adequate.

Your finished product testing found microbiological contamination in products manufactured on (b)(4), on all (b)(4) processors, including, but not limited to the products listed in the table below:

Processor #	Product	Lot #	Date of Manufacture	Microbiological findings
(b)(4)	Oatly Barista Oak Milk	6112(b)(4)	(b)(4)	Gram-negative rods
(b)(4)	Glucerna Vanilla	(b)(4)	(b)(4)	Gram-positive rods
(b)(4)	Glucerna Vanilla	(b)(4)	(b)(4)	Gram-positive cocci and Gram-negative rods
(b)(4)	Redcon1 MRE Protein Shake Cookies N Cream	3112(b)(4)	(b)(4)	Gram-positive cocci
(b)(4)	Redcon1 MRE Protein Shake Milk Chocolate	5112(b)(4)	(b)(4)	Gram-positive rods

All the products listed in the above table were released into commercial distribution and subsequently recalled by you. 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. You did not perform any speciation of finished product microbiological findings until July 2022, when you identified Cronobacter sakazakii in product manufactured on (b)(4); however, this product was not distributed.

Although you were aware of the April 2022 microbiological contamination, your firm did not stop processing until July 15, 2022, and began an internal investigation on July 16, 2022. Your investigation determined that process operators ran Processor (b)(4) for (b)(4) gallons before conducting an (b)(4), not (b)(4) gallons as instructed. You also disassembled the processors and inspected with a (b)(4). Your technicians reported finding a portion of the (b)(4) in the (b)(4) and heating sections of Processor (b)(4) partially blocked with residual product, the (b)(4) on Processor (b)(4) were partially blocked, there was visible residue in the (b)(4) of Processor (b)(4), and there was what appeared to be a dried residual “film” at the (b)(4) flow panel at valve ((b)(4)). This was not the first time in 2022 where your firm had identified product fouling in Processor (b)(4) after the minimum wash flow rates could not be reached during CIP, as your firm identified events on February 13, and April 6, 2022 (though you reported that no blockage was found after you successfully completed your CIP).

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

This is a repeat observation from the FDA inspection conducted May 23 to June 10, 2022, where we observed that a condition of commercial sterility was not achieved for all product contact surfaces (b)(4) from the product sterilizer before starting aseptic processing operations, as required by 21 CFR 113.40(g)(1)(ii)(A). Specifically, Aseptic Tank (b)(4), which feeds your Line (b)(4) aseptic filler required the addition of (b)(4) and (b)(4) to the sterilization procedure to ensure all areas of the aseptic tank meet commercial sterility, as established by your external Process Authority (PA). Prior to May 26, 2022, your Aseptic Tank (b)(4) was not programmed to achieve these parameters and you did not meet the requirements. For example, on (b)(4), you processed Lyons Barista Almond Milk, Item 10165, coded 5012-03. The tank sterilization chart shown as (b)(4), Chart #(b)(4), shows a sterilization procedure starting at approximately (b)(4) and lasting until (b)(4), which is at least (b)(4) short of the time required for this system. Your response dated June 20, 2022, discusses correction of your system set points to match the PA validation and assessed potentially affected product. You state, “All commercial sterility tests: incubated micro and pH have all passed….” However, as discussed in this letter, you were aware of microbial findings in finished product, including Item 10165, Lyons Barista Style Almond Milk, produced on (b)(4), lot 5012-03, at five different timestamps, which resulted in your discard of 1,716 cases of product.

We reviewed your responses to the Form FDA-483 through January 23, 2023. We understand that you have not resumed commercial operations while you have been working with third-party consultants to review and update cleaning, maintenance, and sampling procedures for both your aseptic processing systems and your (b)(4) water system, and plan to track any future microbial recovery as a deviation and to conduct a root cause investigation for all microbial hits. You additionally discuss employee training, review and update of lab practices and procedures, and implementation of a (b)(4). You state this is part of your corrective and preventive actions taken to address the cause of the microbial contamination, which you determined to be primarily caused by ineffective cleaning and sanitation.

Your Root Cause Analysis provided to us at the close of the August 3 to September 14, 2022, inspection identified three factors contributing to the decrease in 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) (b)(4)tank valves were not properly cleaned due to coding errors in your (b)(4) system; and (3) bacteria in your (b)(4) water was likely able to “seed” the system in areas where there was residual build-up or plugged tubes. We note the (b)(4) water was, by design, used to flush the system while the processor was in a non-sterile state during cleaning.

Your response dated October 5, 2022, discusses your corrective and preventive actions, including: verification of processor run rules; water system preventive maintenance enhancements; revision of the allergen preventive control; review and revision of finished product testing program; enhancements to sanitation SOPs to address (b)(4) valves; updates to your CIP and (b)(4) programs with recommendations from (b)(4) and (b)(4); and enhancing action and escalation processes. Your response addresses validation of your (b)(4) for run rules and cleaning practices and discusses an extensive recommissioning and restart plan. We acknowledge that your responses dated December 9, 2022, and January 23, 2023, included some documentation of the activities you have performed as part of your recommissioning runs, including allergen cleaning monitoring records, critical factors processing records, (b)(4) water preventive maintenance records, and microbial testing records for water and finished product. You stated these implementation records are intended to be a representation of the types of records you will be completing during commercial processing.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection to your products. You are responsible for investigating and determining the cause of the violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

In addition to the above violations, we have the following comments about concerns identified during the inspection conducted May 23 to June 10, 2022, as related to your current corrective actions:

1. Processing and production information shall be entered at the time it is observed by the retort or processing system operator, or other designated person. In addition, the following records shall be maintained for an aseptic processing and packaging system: product temperature in the (b)(4) outlet as indicated by the temperature-indicating device and the temperature-recording device; differential pressure as indicated by the differential pressure recorder-controller, if a product-to-product (b)(4) is used; product flow rate, as determined by the flow controlling device or by filling and closing rates; (b)(4) flow rate or temperature or both; retention time of containers, and closures when applicable, in the sterilizing environment; and, when a batch system is used for container and/or closure sterilization, sterilization cycle times and temperatures, as required by 21 CFR 113.100(a)(4).

During the May 23 to June 10, 2022, inspection we observed that actual values were not always recorded or reviewed for critical factors. Specifically, we have the following concerns regarding your electronic recordkeeping system, (b)(4):

a. Operators do not enter any actual values when documenting conditions to bring the Aseptic Sterilizers and Aseptic Tanks to commercial sterility. Instead, operators select (Pass or Fail) in the (b)(4) operator checklist.

For example, your [OP] – Processing – 1.1. – (b)(4) Checklist on April 14, 2022, and [OP] – Processing – 1.1 (b)(4) Run Start for Lyons Almond Milk on (b)(4), document that critical sensors such as the Sterile Air Filters ((b)(4)), (b)(4) Sensor ((b)(4)), (b)(4) ((b)(4)), and (b)(4) were at (b)(4)°F for (b)(4). Operators do not enter any values to ensure the sterilization conditions were actually met and instead indicate only that the condition “passed.” During the production of “Lyons Almond Milk” on (b)(4), operators did not observe and record any values for the critical factor documenting pressure differential ((b)(4)). For example, there are no operator records observing differential pressure for (b)(4).

b. Your (b)(4) record software program does not allow for review of an entire process, as the electronic record maintained in (b)(4) is captured in time specific checks which only allows a reviewer to see individual data points. As such, it does not generate a format suitable for inspection, review, and copying by the FDA, as required by 21 CFR 108.35(h). We identified instances where critical process parameters were not met, and a process deviation was not identified:
• The Initial Temperature (IT) was missed as a critical factor, and the Lower Critical Limits (LCL) set in your system to flag deviations were (b)(4)°F or (b)(4)°F less than your filed process. Your corrective action was to update the system to reflect correct LCLs.
• The Sterilization parameters for Aseptic Tank (b)(4) were (b)(4)°F lower and (b)(4) less than your validation study parameters. We verified you added (b)(4), and you verbally responded you added (b)(4)°F, but no supporting document was provided.

Your response dated January 23, 2023, states for resumption of commercial distribution and going forward, the facility will utilize only paper records, and not an electronic recordkeeping system (i.e., “(b)(4)”), for maintaining and monitoring critical factors. You intend to continue to maintain other electronic records, such as records related to preventive maintenance activities, which you state will be maintained through other software. Your responses through January 23, 2023, also addressed validation of your cleaning practices and run rules, and steps you state you have taken to “recommission” your entire system in a phasal approach. We will review your corrective actions and implementation thereof during our next inspection.

2. Whenever any process is less than the scheduled process or when critical factors are out of control for any low-acid food or container system as disclosed from records by processor check or otherwise, the commercial processor of that low-acid food shall either fully reprocess that portion of the production involved, keeping full records of the reprocessing conditions or, alternatively, must set aside that portion of the product involved for further evaluation as to any potential public health significance. Such evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Unless this evaluation demonstrates that the product had been given a thermal process that rendered it free of microorganisms of potential public health significance, the product set aside shall be either fully reprocessed to render it commercially sterile or destroyed. A record shall be made of the evaluation procedures used and the results. All process deviations involving a failure to satisfy the minimum requirements of the scheduled process shall be recorded and made the subject of a separate file process, detailing those deviations and the actions taken, as required by 21 CFR 113.89.

During our inspection dated May 23 to June 10, 2022, we observed that for process deviations reviewed in-house you do not document sufficient information to determine what information was used to “clear” a deviation. For example, four out of 11 deviations reviewed during the inspection were for instances where product was observed to be leaking either (b)(4), or at an aseptic tank valve. These deviations were released by your internal PA with no information documented as to what occurred, where product leaked, and no additional testing was performed to support product release. For example, QA-305: Plant Protein and Superfood Beverage, Golden Vanilla Flv, lot 5921-04, manufactured on (b)(4). QA log indicates “Product Leak on (b)(4) tank (b)(4).”

Your response dated June 20, 2022, states, “These specific instances were listed as ‘deviations’ by quality technicians on an initial communication alert document utilized by our quality team in real time. The intent of the document is to alert the Quality, Production and Director Process Control (internal PA) of any issue or potential issue” and, also, “In these specific cases the situations were reviewed real time by the Director of Process Control – (Internal PA) and deemed there was no actual product leak or impact to product hence no ‘deviation.’” You note that your internal PA did not retain a record of this assessment. Your corrective actions state your “Quality Alert System has been updated so that a formal review and editing function is available for management and PA to capture the assessment in the same location and be filed with the report/log.”

During our most recent (August 3 to September 14, 2022) inspection, we followed up on your response and corrective actions for this observation. Your firm provided more information for event QA-305, a lot for which we received a consumer complaint:
• At (b)(4) on October 22, 2021, there was a leak at the clamp of (b)(4) Tank (b)(4). Work Order 223654 noted the divert valve for (b)(4) Tank (b)(4) was rebuilt (b)(4). You acknowledged your internal PA was not at the facility when the event occurred.
• Your Quality Alert Notice notes 984 cases subject to this “HACCP [Hazard Analysis Critical Control Points] Deviation” or “Loss of Sterility” were placed on hold. Your firm was unable to produce records during our inspection that showed any increased evaluations occurred on these cases prior to their release into distribution.

Your production employees acknowledged a significant event had occurred which affected product, noting a HACCP Deviation of “Loss of Sterility,” and documented that event as a Quality Alert Notice per your procedures at the time. Your management team responsible for review and escalation of Quality Alert Events failed to escalate and respond to this event as a HACCP deviation. Additionally, your initial response in June 2022 discusses implementation of an editing function for management in your Quality Alert System, which was identified as a system used as an official record for operator observations. During our August 3 to September 14, 2022, inspection you acknowledged that initial observations can be removed from the system when making edits, in violation of 21 CFR 113.100(h). We knowledge that you recalled all products manufactured at this facility, and that you updated your procedure “Process Deviation Procedure Q1 (b)(4),” effective October 25, 2022, to define and document product leaks (b)(4) as a Process Deviation. We will review your handling of process deviations during our next inspection.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant. We also remind you that if you do not adhere to all the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113, you could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344).

Please notify FDA in writing within 15 working days from your receipt of this letter, of specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your reply should be addressed to Carolyn Warren, Compliance Officer, U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Ms. Warren at (612) 758-7182 or via e-mail at Carolyn.Warren@fda.hhs.gov.

Sincerely,

/S/

CAPT Christopher van Twuyver
Acting Program Division Director, West 1
Office of Human and Animal Food Operations
 

cc: Stephen R. Twet
SVP / Chief Quality Officer
Lyons Magnus, LLC
3158 East Hamilton Avenue
Fresno, CA 93702

Shane S. Solberg
Vice President, Low-Acid Operations
Lyons Magnus, LLC
2924 Wyetta Drive
Beloit, WI 53511-3964