Here is a summary of that report highlighting the big misses that occurred within the Company's Preventive Control Program. This is an excellent example why a proper Food Safety Plan is needed.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/old-europe-cheese-inc-644539-03172023
WARNING LETTER
- Presence of Outbreak Strain of Listeria "FDA collected samples (environmental swabs) of the production environment and confirmed that (1) swab collected from a hole in the (b)(4) floor was positive for L. monocytogenes. WGS analysis was conducted of the above referenced L. monocytogenes isolate and it was determined that the environmental isolate matched the six (6) clinical isolates that were part of an illness outbreak cluster.
- Presence of Listeria Indicator Organisms - In addition to L. monocytogenes, the presence of Listeria innocua (L. innocua) was also found in your facility during the FDA environmental swabbing that occurred on September 13 and 14, 2022. L. innocua was detected in two (2) environmental swabs taken from the floor in the (b)(4) Room and a floor drain between the (b)(4) Room and (b)(4) Hallway where the cheese products are RTE (post-pasteurization) and exposed to the environment. The presence of non-pathogenic Listeria species suggests that conditions are suitable for survival and/or growth of L. monocytogenes which, as noted above, has been found in your facility.
- Hazard Analysis Does Not Consider Environmental Contamination by Pathogens a Significant Hazard - "The "hazard analysis for soft and semi-soft cheese products determined that “Post-Pasteurization Contamination” did not require a preventive control because it was “Unlikely to occur as purity plating of production samples is performed and plant performance history indicates good process control.” In addition, your hazard analysis determined that “Environmental Contamination (Listeria)” did not require a preventive control because an “Environmental program is in place to test for listeria spp. Finished product testing is also performed with positive release program.” However, RTE soft and semi-soft cheese products manufactured in your facility were exposed to the environment at various post-pasteurization processing steps (e.g., (b)(4))"
- Hazard Analysis Does Not Consider Finished Product Cooler Temperature as a Process Preventive Control - "Hazard analysis did not require a preventive control at the “Cooler Storage” step because a “Program for Cooler Temperature [sic] Control is in place. Plant does not have a history of problematic room temperatures.” However, if not properly time/temperature-controlled, the RTE soft and semi-soft cheese products stored in your facility are likely to support the growth and toxin formation of bacterial pathogens (such as ingredient-related pathogens either surviving pasteurization or added post-pasteurization, or environmental pathogens introduced in your facility). "
- Deviation to Cooler Temperature - "Through record review during the inspection, we detected two (2) dates where temperatures were recorded as 51.2°F, 52°F and 53.1°F with no record of a corrective action documented. Soft cheeses can support the growth of pathogens, including L. monocytogenes, when not stored at proper refrigeration temperatures."
- The Hazard Analysis Does Not Properly Address Post-Process Ingredient Additions with Supply Chain Preventive Controls - The "hazard analysis for soft and semi-soft cheese products determined that bacterial pathogens in many ingredients added after pasteurization (e.g., peppercorns, 1/8” flaked tomato, chives, basil, garlic salt, and parsley) did not require a preventive control because “Product is tested for Salmonella – COA Received per lot.” These ingredients did not undergo a kill step in your facility. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control (i.e., supply-chain program)."
- Sanitation Procedures Not Fully Implemented - with respect to the production of soft cheeses when they are RTE (post-pasteurization). For example:
- The "sanitation procedures, as described in the document titled, “GMP Manual,” instructed employees to wash their hands “following practices that may compromise hand cleanliness.” However, on September 13, 2022, our investigators observed two (2) different employees’ hands come into contact with unclean surfaces (e.g., a hose that had been in contact with the floor); these employees (b)(4) their hands into a (b)(4) and returned directly to handling RTE brie cheese without washing their hands."
- The "Master Sanitation Schedule directed employees to clean-in-place (CIP) the brie vats with both (b)(4) solution according to the production schedule. However, our investigators observed during the CIP on September 15, 2022, that the vat was only filled to approximately (b)(4) of its volume, which resulted in the food-contact surfaces inside not being fully submerged, as would be needed to facilitate effective cleaning. One of your employees also indicated that (b)(4) solution is not always used in the vats during the week, contrary to the instructions in the Master Sanitation Schedule."
- Not Following the Environmental Monitoring Program - "Environmental Swabbing program required collection of a minimum of (b)(4) samples from designated zone 2-4 locations every (b)(4). However, you collected ten (10) swabs on or around May 25, 2022, and then you stated that you did not collect any more swabs until the week of this inspection, on or around September 14, 2022."
- Improper Cleaning - "did not conduct cleaning and sanitizing of utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). Specifically, on September 13, 2022 employees were observed spraying the outside of brie vats and the floor around the vats with a hose in such a manner that spray from the hose was observed contacting the floor and subsequently contacting the adjacent cheese molding machine."
- Condensation Issues - "Condensation was observed throughout the facility including on areas above cheese molding equipment and RTE brie cheese. For example, condensation and dark reddish-brown stains were observed on the ceiling directly over at least ten racks of stacked food-contact cheese molds stored in the Clean Room. Clear condensation was also observed on pipes and the ceiling within two feet of exposed RTE brie cheese in (b)(4) Room (b)(4). Condensation was also visible on the walls and windows near the ceiling of the (b)(4) Room where food-contact cheese molds were observed sitting on racks exposed to the environment in this room for approximately three hours before being moved to the (b)(4) Room."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/old-europe-cheese-inc-644539-03172023
WARNING LETTER
