FDA WARNING_LETTER - Hans Kissle Company, LLC - April 05, 2019

The FDA inspected Hans Kissle's RTE salads and prepared foods facility in Haverhill, MA, from March 9 to April 5, 2019, revealing serious violations of the CGMP & PC rule (21 CFR 117). Environmental samples confirmed *Listeria monocytogenes* (L. monocytogenes), including a strain found in 2017 and 2018 inspections, indicating a resident pathogen. This renders the RTE foods adulterated under 21 U.S.C 342(a)(4).

Violations include inadequate sanitation controls (21 CFR 117.135(a)(1), (c)(3)) as evidenced by the persistent L. monocytogenes strain and the presence of non-pathogenic *Listeria* species. Specific failures in implementing written sanitation procedures (SSOP-003 and SSOP-002) were observed, such as improper segregation of clean/unclean equipment and insufficient cleaning of equipment. The facility also failed to implement its supply-chain program (21 CFR 117.405(a)), not receiving required Certificates of Analysis for RTE diced vegetables and feta cheese. Furthermore, the facility failed to conduct food manufacturing under conditions to minimize contamination (21 CFR 117.80(c)(2)), with RTE vegetables staged in high-traffic areas and unsanitary practices during product