Wise Spice Catering Company
Outcome
FDA issued a warning letter on March 8, 2023, after finding 19 of the facility's environmental swabs positive for Listeria monocytogenes during an August 2022 inspection of Wise Spice Catering Company's Hialeah, Florida RTE food facility — including on food-contact surfaces used in RTE sandwich and salad preparation — and citing serious violations of FSMA preventive controls requirements.
Details
Wise Spice Catering Company — 19 Listeria-Positive Swabs / FDA Warning Letter (2023)
Outcome: FDA issued a warning letter on March 8, 2023, after an April 19–August 1, 2022 inspection of Wise Spice Catering Company's Hialeah, Florida ready-to-eat food facility found 19 environmental swabs positive for Listeria monocytogenes — including on food-contact surfaces of a preparation table and a container used to hold raw produce for RTE sandwiches and salads — constituting serious violations of FSMA's preventive controls requirements under 21 CFR Part 117.
Wise Spice Catering Company operates a ready-to-eat food manufacturing facility in Hialeah, Florida producing catered sandwiches, salads, and other RTE food items. FDA investigators conducted a comprehensive inspection of the facility from April 19 through August 1, 2022 — a notably extended inspection period spanning multiple visits. The inspection included collection of environmental swabs throughout the facility; laboratory analysis confirmed that 19 of the collected swabs were positive for Listeria monocytogenes.
The contamination was not limited to non-food-contact environmental surfaces. Positive swabs were recovered from the food-contact surface of a preparation table used in RTE food production and from a black milk crate that held raw produce used as ingredients in RTE sandwiches and salads. Positive Listeria findings on food-contact surfaces represent direct adulteration risk to finished products that contact those surfaces.
The warning letter, issued March 8, 2023, cited serious violations of the CGMP and preventive controls requirements of 21 CFR Part 117. Specific citations addressed the facility's failure to implement adequate sanitation controls for Listeria monocytogenes in its RTE production environment and the failure to identify and correct the pathogen hazard through its preventive controls program. No product recall was publicly announced in connection with this warning letter.
Primary Source: FDA Warning Letters | FDA
How Crucible Prevents This
Nineteen positive Listeria swabs from a single FDA inspection — including from food-contact surfaces of prep tables and raw produce-holding containers used in RTE sandwiches — indicates a facility where environmental sanitation monitoring was either not being performed or was not surfacing results that triggered corrective action. Crucible's session-gate enforcement requires documented environmental monitoring sign-off before each production day: a 19-positive result would be structurally impossible to accumulate in a facility operating under daily sanitation verification with required sign- off and corrective action escalation.
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