Listeria in facility and in product
- FDA "found that nineteen (19) swabs were confirmed positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from the food-contact surface of a prep table in the (b)(4) Room used in the assembling of your RTE closed faced sandwiches, and one (1) swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time L. monocytogenes was found in environmental samples collected in your facilities building. In 2020, FDA detected L. monocytogenes in six (6) environmental swabs; in 2018, FDA detected L. monocytogenes in nine (9) environmental swabs; and in 2017 FDA detected L. monocytogenes in eighteen (18) environmental swabs."
- "Based on the results of the WGS analysis, these isolates represent eighteen (18) different strains of L. monocytogenes. The WGS analysis identified multiple strains of L. monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in your facility."
- Many of these strains were found in different product samples tested since 2015.
GMP issues
- Ineffective measures to exclude pests from packing and holding areas with sightings of cockroaches and flies.
- Drip / condensate falling from from fixtures, ducts and pipes
- Improper cleaning including the use of unclean utensils
- Inadequate temperatures control
As of this issuance, the company looks to be be permanently closed.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wise-spice-catering-company-640715-03082023
FDA Warning Letter - Wise Spice Catering Company