FDA issued a warning letter ready-to-eat RTE prepared foods manufacturing facility that produced RTE salads. There are issues with the Preventive Control Plan as well as GMP issues. One of the interesting items regarding their plan was that they were not following it. Item number 3 below points out how many people write up a plan, and in that plan, they overstate what they do.
1)
Listeria was found in the facility, the same strains of Listeria that were found in previous inspections - "FDA collected environmental samples from various areas of your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2017 and 2018 inspections". "Whole Genome Sequencing (WGS) of isolates detected in the FDA environmental samples identified six (6) isolates with the same strain of L. monocytogenes. Specifically, the same strain of L. monocytogenes was identified in three (3) isolates from environmental samples collected during the 2019 inspection, one (1) isolate collected from your facility in April 2018, and two (2) isolates collected from your facility in September 2017."
Because of this it can be stated that Sanitation Preventive Controls were not adequate -
The facility "identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary"
2)
FDA identified SSOPs that were not being followed - The company "did not implement the written sanitation control procedures identified in your SSOP entitled "
3)
The company did not follow their own Supplier Preventive Controls - the Plan "states that Certificate of Analysis (CoA) “must be received prior to or on the date of ingredient delivery for all ingredients unless expressly exempted by Hans Kissle QA” and must contain “physical, chemical and microbiological test results for the specific lot number or code of the product.” It was observed that you do not receive CoA’s for RTE/refrigerated diced vegetables and RTE/refrigerated feta cheese that are used in the production of RTE Aegean Greek Pasta Salad. Although you indicated that you have an “exempt list,” these suppliers were not named on this list. Additionally, no further kill step is applied to the diced vegetables and feta cheese in the production of RTE Aegean Greek Pasta Salad. Note that when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, the appropriate default supplier verification activity is an onsite audit of the supplier"
4)
GMP issue- Food stored directly on ground - "bags of RTE vegetables, including one (1) open bag of RTE carrots and one (1) torn bag of cucumbers, were staged on the floor of the hallway (b)(4) room. This area was observed to be a high employee and equipment traffic area. These bags of RTE vegetables are removed from their outer boxes in the hallway and placed onto plastic pallets or plastic totes adjacent to this area, (b)(4) was being washed and sanitized using (b)(4) that occasionally sprayed beyond the (b)(4) into the area where the vegetables were stored.
5)
GMP issue - leaking valves through the facility - "during the most recent inspection of your facility, the following equipment conditions were observed in areas where there is significant handling of RTE product and employee movement"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hans-kissle-company-llc-584080-09242019
WARNING LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 — September 24, 2019
