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December 7, 2021

WARNING LETTER

Refer to CMS 617124

Dear Mr. Dickinson:

The United States Food and Drug Administration (FDA) conducted an inspection of your tolling operation for dry milk powder processing located at 140 S. Concord Road, Oconomowoc, Wisconsin, on May 26-27, June 8-9, 14-15, 17, 24, and July 19, 23, 2021.

During our inspection of your facility FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility, including areas that are in close proximity to food and food-contact surfaces. FDA laboratory analyses of the environmental samples found the presence of Salmonella enterica serovar Cubana Group G (hereinafter Salmonella Cubana), a human pathogen, in your facility. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the ready-to-eat (RTE) dry milk powder processed at your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), Title 21, United States Code (21 U.S.C.) § 342(a)(4), in that it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act, 21 U.S.C. § 331(uu). You may find the Act and further information about the CGMP & PC rule through links on FDA’s internet home page at http://www.fda.gov.

The deviations observed during the inspection were outlined in a Form FDA-483, Inspectional Observations, issued to you at the close of the inspection. We received your email response dated August 13, 2021. After reviewing the inspectional findings and your written response, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-based Preventive Controls (21 CFR 117, Subpart C):

1. You did not identify and implement preventive controls adequate to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, 21 U.S.C. § 342 or § 343(w), to comply with 21 CFR 117.135(a)(1).

Your facility processes agglomerated milk powders that are sold for further blending into beverages or for further packaging, and are considered RTE because they are consumed without further processing to significantly minimize biological hazards. Your hazard analysis identified environmental pathogens as a hazard requiring a preventive control at the (b)(4) step (b)(4) and the filling/packaging step (after agglomeration), where RTE powder is exposed to the environment. You identified sanitation preventive controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of Salmonella Cubana in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen of Salmonella, as required by 21 CFR 117.135(a)(1) and (c)(3).

On June 14 and 15, 2021, FDA collected environmental samples INV 1012709 and INV 1012710 during the production of whey protein isolates and whey protein concentrate. FDA laboratory analysis confirmed 10 of 174 environmental swabs collected were positive for Salmonella Cubana. Of these positive findings, three positive swabs were collected from the (b)(4) room, a room that you consider a primary pathogen control area where products are exposed to the environment and include the following locations: a crack in the wall and floor junction adjacent to (b)(4); the floor and stair junction of the mezzanine level which employees climb to access ribbon blenders; and the floor drain cover adjacent to the mezzanine stairs. Additionally, three positive swabs were collected from the agglomeration room, including the equipment framework under Line (b)(4).

Whole genome sequencing (WGS) was conducted on the Salmonella isolates obtained from the 2021 FDA environmental samples, and the current WGS analysis determined that the 2021 isolates matched isolates from three other environmental samples including FDA sample 437365, FDA sample 892439, and FDA sample 940886, which were collected from this facility location in 2009, 2016, and 2017, respectively. The presence of the same strain of Salmonella over multiple years indicates there has been a resident pathogen in your facility since at least 2009. We advised you of the WGS results via a conference call on July 22, 2021. We note that the Salmonella findings from 2009, 2016, and 2017 were detected while your facility was under previous ownership; however, during this WGS call, you indicated that you were aware of the past Salmonella findings within your facility. You further indicated that you submitted some of your positive swabs for serology and found the same serotype as the previous company’s findings.

These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent Salmonella in your facility. Once Salmonella is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow and take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-estabished in such sites.

Additionally, at the time of the inspection your hazard analysis indicated that environmental pathogens such as Salmonella would be covered by your GMP program instead of sanitation preventive controls at the (b)(4) steps. Your reasoning was that the product is (b)(4) at these steps and not exposed to the environment or employee handling. However, during the inspection FDA investigators observed areas where product is exposed to the environment during these steps, including the (b)(4) at the (b)(4) step which are (b)(4) for powder sample collections for moisture testing. In addition, wet powder was observed leaking out the sides of the drying equipment, and dried product accmulations were observed along the outside framework of the drying (b)(4). Also, powder residue was observed on walkways and floors of the agglomeration room (b)(4).

Furthermore, in reviewing your facility’s environmental monitoring program, we note that you have repeatedly found Salmonella through your own testing. In response, you generally have performed vector swabbing, recleaning/resanitizing, and reswabbing. However, it appears that your corrective actions have not been adequate to address your findings and the hazard of Salmonella. For sample, on May 20, 2021, through routine environmental monitoring, you detected Salmonella on a green squeegee stored in the agglomeration room. You performed vector swabbing on the squeegee and surrounding area prior to cleaning on May 24, 2021, which resulted in five additional positive results for Salmonella. The area was recleaned/resanitized and reswabbed on May 28, 2021. Although all sites previously found positive were then found negative, two new positive results were obtained on the floor under belts in the agglomeration room. On June 8, 2021, you took additional corrective actions to reclean and resanitize, including (b)(4). Production resumed in the room, and reswabbing on June 9, 2021, resulted in five new positive results. On June 14, 2021, FDA conducted environmental sampling in the agglomeration room and detected the presence of Salmonella, as described above. One of these positive sites was the same area (the drain under the stairs in between the (b)(4) belts on (b)(4)) where you detected Salmonella during your swabbing on June 9, 2021.

During our call to relay WGS results, you stated that you conducted cleaning and sanitizing of the FDA positive swab sites, reswabbed the areas, and obtained negative results. Your written response indicated that you revised your food safety plan and added sanitation preventive controls at the (b)(4) steps. Your response also indicated that you purchased (b)(4) to (b)(4) in the facility (which you attributed as a factor in environmental Salmonella) and that you are purchasing (b)(4) for (b)(4) to treat the environment. Your response further indicated that you conducted corrective action cleaning and swabbing until results demonstrated the “environment was brought up to sanitary conditions” and that you have hired a full-time sanitation employee and production supervisor to ensure the production environment is maintained in a sanitary condition. However, your response did not fully explain how you investigated the source of the Salmonella to determine that you have located and eradicated the harborage site(s) or provide supporting documentation to show that you have implemented your corrections (e.g., revised Food Safety Plan, sanitation records, or environmental sampling results).

We are concerned about your ability to maintain a sanitary environment based on the numerous Salmonella positives that were found in your facility through your own and FDA’s environmental sampling, including at repeat sites. We recommend that you continue to conduct a root cause analysis and identify potential harborage sites and source(s) of the organism in your processing environment and take all necessary actions to eliminate Salmonella from your facility and ensure your food products are not contaminated. In a facility in which there have been ongoing Salmonella contamination problems, eradication of harborage sites can be difficult and can involve construction. If construction activities within the production area become necessary to eliminate potential harborage sites, we recommend you conduct an assessment of risk to determine whether or not such activities can take place while you are in production without potentially contaminating product and existing equipment and areas where production continues. If production continues during eradication of harborage sites in areas that could impact production, you should identify and implement appropriate controls to limit the potential impact (e.g., spread of any Salmonella) of such activities to other areas of your facility and take appropriate steps to re-establish sanitary conditions in affected areas once such activities are complete.

2. You did not establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which you have identified a hazard needing a supply-chain-applied control, as required by 21 CFR 117.405(a)(1).

Your hazard analysis identifies Salmonella as a hazard requiring a preventive control at your lecithin receipt step, due to the risk of introduction of pathogenic microorganisms from improper handling/processing at the supplier level. Your hazard analysis indicates that this hazard will be controlled through your supply-chain program, as you do not currently consider your agglomerated milk powder processing as a kill step for pathogens in ingredients. As part of your supply-chain program, you established a Supplier Approval Program dated November 11, 2019. This procedure states that, among other things, a copy of the current third-party audit certificate will be reviewed prior to using an ingredient in production. However, your review of onsite audit documentation for supplier (b)(4) covered a different supplier location than where the lecithin ingredient is actually manufactured. The Food Safety System Certification audit certificate that you reviewed was for a firm in the (b)(4), but a Continuing Letter of Guarantee provided by (b)(4) indicated that the lecithin originated from (b)(4).

Your written response indicated that the lecithin ingredient is, in fact, manufactured at a supplier location in (b)(4), for which you obtained a third-party audit certificate. Note that audit procedures and the conclusions of the audit must be documented to comply with 21 CFR 117.475(c)(7), so review of an audit certificate may not be adequate, depending on its content. You did not provide the certificate for our review so we cannot evaluate what the audit covered and concluded.

Furthermore, the audit certificate for (b)(4) in (b)(4) was dated June 7, 2019 (more than two years before the FDA inspection ended). Your Supplier Approval Program requires review of approved suppliers (b)(4). However, Salmonella in RTE lecithin is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled, 21 CFR 117.430(b). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter, 21 CFR 117.430(b)(1)(ii).

In addition, for new suppliers of ingredients, your procedure requires that “micro testing will be done on (b)(4) lots of each incoming material for qualification” to “ensure compliance with established specifications.” However, when you approved (b)(4) as a supplier, you did not conduct testing on the lecithin ingredient.

Your written response indicated that you have reviewed your supplier program and that testing of ingredients by the facility has been eliminated. You now require new suppliers to submit an original laboratory report along with a Certificate of Analysis. However, you have not provided an updated version of your supplier program for our review.

Current Good Manufacturing Practice (Subpart B):

1. You did not conduct all food manufacturing, processing, packing, and holding under conditions and controls necessary to minimize the potential for the growth of microorganisms and contamination of food, as required by 21 CFR 117.80(c)(2). Specifically:

A. FDA investigators observed various pieces of production equipment leaking in multiple areas of the plant. In particular:

i. On June 8, 2021, water was leaking from the back end of the (b)(4) belt on Line (b)(4) in the agglomeration room. Product inside and on the belt was observed to be clumped and what appeared to be evidence of water dripping and running through the powder was visible. The line had not run since the prior evening, but contained product to be processed when production resumed. You swabbed the food-contact surface of this equipment and submitted the swabs that day to be analyzed. Analysis found that four of these swabs had greater than 570,000 colony-forming units (CFUs) of coliforms. (b)(4), was being processed on the line as part of an extended run that began on June 8, 2021, and finished product testing for June 9, 2021, showed a result of 4,100 CFUs for aerobic plate count.
ii. On June 8 2021, liquid was leaking from (b)(4) onto the floor in the agglomeration room. On June 9, 2021, you swabbed the floor under (b)(4) and detected Salmonella.
iii. On June 8, 2021, lecithin tank (b)(4) was leaking from the bottom and water was splashing onto the floor of the (b)(4). On this date, and again on June 14, 2021, water was leaking under the wall of the (b)(4) to a drain immediately in front of the overhead door entrance to the dry ingredient (b)(4) room. Through your routine environmental sampling of the vestibule area ((b)(4)), Salmonella was detected on the doorknob to the (b)(4) on May 20, 2021. Vector swabbing on May 24, 2021, revealed an additional positive result for Salmonella on a brick half-wall leading to the packaging area.
iv. On June 14, 2021, water was leaking on the floor of the (b)(4). It appeared to be originating from a pump located in a corner of the room, next to the overhead door leading to the warehouse. FDA swabbed the floor in the area on June 14, 2021, and it was positive for Salmonella.

Contamination from the leaks onto the floor may be spread throughout your production area via employee and equipment traffic. Your written response indicated that replacement parts have been ordered and that adjustments have been made to replace and to repair leaking equipment. In addition, you indicated that you are working with a process engineer consultant to (b)(4) and that you are working with a contractor to maintain the (b)(4) system. However, you did not provide specific information demonstrating corrections made, including consultations with third parties, details on specific parts ordered, and photos depicting completed repairs.

B. FDA investigators observed the following practices related to the operation of fork lifts during production:

i. On June 8 and 14, 2021, employees drove the white forklift into the warehouse to pick up pallets of ingredients and return to the (b)(4) room. The front right tire of the white forklift was swabbed by FDA on June 14, 2021, and found to be positive for Salmonella.
ii. On June 8, 2021, the yellow forklift was used to deliver pallets of material into the (b)(4) room. The yellow forklift generally operates in the warehouse, including transporting dumpsters to the trash compactor to be emptied.

Contamination from the floor of non-production areas may be spread to and throughout your production area via forklift tires. Your written response indicated that employee traffic flow for the (b)(4) room has changed and that employees have been instructed to exit using designated doors. Your response also indicated that a new pallet jack has been ordered and that employees are instructed in their dedicated use. However, your response did not provide supporting documentation demonstrating any corrections made or include any training records.

2. You did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b). Specifically, on June 9, 2021, production employees were observed recleaning/resanitizing areas of the floor in the agglomeration room that were not cleaned thoroughly during sanitation earlier that day. The employees were on their hands and knees on the floor, using a bucket and rag. However, these employees were not wearing fresh uniforms later in the day when handling the equipment and product.

Your written response indicated that employees have been retrained on the sanitation program, focusing on changing practices after cleaning and sanitizing has been conducted. However, your response did not provide training records.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so 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.

In addition to the violations described above, we offer the following comments:

On June 14, 2021, a vacuum attachment used to clean the floor of the agglomeration room was observed stored in an animal feed bin. FDA swabbed this attachment while it was in the animal feed bin and Salmonella was detected.

Your written response indicated that employees are instructed in the (b)(4) of vacuum attachments. Your response further indicated that food-contact or non-food-contact attachments are stored separately and are cleaned at specified frequencies according to your cleaning schedules. Your response added that the attachment which tested positive for Salmonella was disposed of, and you are in the process of (b)(4). However, you did not provide supporting documentation demonstrating corrections made or any training records.

In addition, during the inspection FDA investigators observed product intended to be sold for animal food is filled and packed in the (b)(4) room, which is also used to store baled cardboard and other miscellaneous items. Salmonella has been detected in this room through your facility’s environmental sampling program and also was detected by FDA in two swabs near the tote filler and at the floor entrance from the warehouse/packaging areas. FDA investigators observed spilled powder on the tops of stored totes and on pallets, and some of this powder had what appeared to be insect trails through it. Additionally, one pallet holding (b)(4) paper bags of product appeared to have become wet during storage, and a small pool of water under a (b)(4) valve was located near this pallet.

Your written response indicated the (b)(4) room has been added to your master sanitation schedule and that this area has been added to your GMP inspections for monitoring. In addition, your response indicated that a designated pallet jack will be used in the (b)(4) room. However, we remind you that human food by-product intended for distribution as animal food must be held under conditions that will protect against contamination, as required by 21 CFR 117.95(a) and 21 CFR 507.28. FDA’s Center for Veterinary Medicine (CVM) has adopted Compliance Policy Guide (CPG) 690.800, “Salmonella in Food for Animals,” that addresses the presence of Salmonella in animal food: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-690800-compliance-policy-guide-salmonella-food-animals. CVM has also developed Guidance for Industry (GFI) #239, “Human Food By-Products for Use as Animal Food”: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-239-human-food-products-use-animal-food. Both documents provide guidance on distribution of human food by-products as an ingredient to be used in animal food.

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

Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection, assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B).

For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs to your facility.

Your response should be sent to Boun M. Xiong, Compliance Officer, U.S. Food and Drug Administration, 250 Marquette Avenue South, Suite 600, Minneapolis, Minnesota, 55401, or by email to [email protected]. If you have any questions regarding any issues in this letter, please contact Compliance Officer Xiong at (414) 326-3976.

Sincerely,
/S/

Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations