FDA WARNING_LETTER - Wise Spice Catering Company - August 01, 2022

The FDA inspected a ready-to-eat (RTE) food facility in Hialeah, Florida, from April 19 to August 1, 2022, finding serious violations of the CGMP & PC rule (21 CFR Part 117). Environmental swabs revealed *Listeria monocytogenes* (L. mono) in 19 samples, including food-contact surfaces. This is a recurring issue, with L. mono detected in 2017, 2018, and 2020 FDA samples, and 2015 USDA/FSIS samples. Additionally, Florida Department of Agriculture and Consumer Services (FDACS) found L. mono in finished Ham, Egg and Cheese Sandwich and Beef, Beans Rice Cheese Burrito products in May 2022, leading to a Stop Sales Order and Destruction, and a Stop Use Order for a preparation room. FDACS also found L. mono in finished products in 2015. Whole genome sequencing (WGS) identified 18 different L. mono strains, indicating resident pathogens.

The facility also violated CGMP regulations by failing to exclude pests (cockroaches, flies, bird excreta observed), prevent contamination from condensation dripping onto food/surfaces, maintain clean and sanitary conditions (stagnant water, unclean knife), and hold RTE foods at proper temperatures (scrambled eggs and yuca held at unsafe temperatures for extended