The Warning Letter discussed here is a good example of not properly identifying and implementing a Sanitation Preventive Control in a RTE facility. This facility had an ongoing Listeria contamination issue that had was not rooted out and eliminated.
FDA environmental testing revealed that the clinical isolates match two (2) environmental swabs taken from production area during the FDA inspection of the facility (March 31 to April 15, 2025).
Did not consider environmental pathogens as a significant hazard warranting a preventive control, because of using prerequisite programs (SSOPs) - "While the facility’s written hazard analysis considered biological pathogens such as L. monocytogenes at the RTE product preparation, assembly, and (b)(4) steps, they determined this hazard was not reasonably likely to occur and did not require a preventive control due to your Sanitation Standard Operational Procedures (SSOPs) and Good Manufacturing Procedures (GMPs). However, your RTE products are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."
Did not consider environmental pathogens as a significant hazard warranting a preventive control, because of using prerequisite programs (SSOPs) - "While the facility’s written hazard analysis considered biological pathogens such as L. monocytogenes at the RTE product preparation, assembly, and (b)(4) steps, they determined this hazard was not reasonably likely to occur and did not require a preventive control due to your Sanitation Standard Operational Procedures (SSOPs) and Good Manufacturing Procedures (GMPs). However, your RTE products are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."
Their approach was shown to be inadequate "as evidenced by the following analytical results, the SSOPs and GMPs are not adequate to ensure that [the] facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of environmental pathogens such as L. monocytogenes
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/compass-group-usa-709592-09052025
WARNING LETTER
Compass Group USA
MARCS-CMS 709592 — September 05, 2025
The positive findings included the food-contact surfaces of a:
- Conveyor belt and roller where in-process RTE sandwiches were placed.
- Slicer 3-gauge plate/knife cover which is used to slice component ingredients for RTE sandwich and wrap products.
Interesting was that this was not the first time L. monocytogenes was found in the facility by FDA. "In 2017, FDA detected L. monocytogenes in (b)(4) environmental swabs, which included a swab collected from a direct food-contact surface taken from a mixing bowl. The company indicated they would implement corrective actions at that time. However, the "reoccurring presence of L. monocytogenes in [the] facility is significant in that it demonstrates [the] sanitation efforts have been inadequate to effectively control or prevent L. monocytogenes in your facility so as to prevent contamination of food."
The company indicated they took corrective action after the FDA inspection, however, they did not provided sufficient verification to FDA that the measures taken were adequate. The report states that the company has "not provided any additional information regarding your investigation on identifying the sources of L. monocytogenes to show that you have located and eradicated the harborage site(s), your updated food safety plan, your revised sanitation preventive control program, details regarding your revised environmental monitoring program to identify the target test microorganism, and the analytical methods you will be using. You also did not provide any of your associated cleaning and sanitation records to reflect your corrective actions, and you did not provide any training records that demonstrate your employees have been trained in proper sanitation."
Other issues
- Metal control - did not appropriately evaluate physical hazards such as metal, to determine whether it is a hazard requiring a preventive control in your RTE products.id not have adequate controls in place, as evidenced by missing metal lacing segments observed on Lines (b)(4) conveyor belts on March 31, 2025. Further, product manufactured on Line (b)(4) did not pass through a metal detector. Missing metal lacing segments is a repeat observation from our previous inspection of your facility.
- Supply chain program for RTE Ingredients - 'did not appropriately evaluate the hazard of biological pathogens associated with the ingredients as a known or reasonably foreseeable hazard requiring a preventive control, although there is a vendor approval program for ingredients. The facility produces ready-to-eat products containing ingredients with reasonably foreseeable biological hazards (specifically, chilled RTE produce) that do not undergo a validated (b)(4) step or other adequate lethality treatment within your facility to eliminate these identified hazards. Therefore, for those ingredients, one is required to establish and implement a supply chain program'
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/compass-group-usa-709592-09052025
WARNING LETTER
Compass Group USA
MARCS-CMS 709592 — September 05, 2025
