FDA WARNING_LETTER - Whitsons Food Service (Bronx), LLC - November 21, 2018

The FDA inspected a Ready-To-Eat (RTE) food manufacturing facility in Islandia, NY, from October 30 to November 21, 2018, uncovering serious violations of the CGMP & PC rule (21 CFR Part 117) and the Seafood HACCP regulation (21 CFR Part 123). Environmental samples confirmed the presence of *Listeria monocytogenes* (L. monocytogenes), including persistent strains, in the facility and on equipment provided to another facility, rendering RTE products adulterated under 21 U.S.C. § 342(a)(4). Key deficiencies included the failure to identify environmental pathogens as a hazard requiring preventive control in food safety plans for RTE products, and inadequate implementation of allergen preventive controls, specifically mislabeling RTE Thai Noodle Salad. Corrective action procedures for chilling cooked products were insufficient to address affected food, and process controls lacked appropriate parameters for bacterial growth prevention. The facility also failed to maintain plant repair, evidenced by L. monocytogenes positive holes in the salad room floor. Furthermore, the Seafood HACCP plan for tuna products had an inadequate critical limit for pH to control *Clostridium botulinum* growth, and the firm failed to take appropriate corrective actions for time and temperature abuse deviations in RTE tuna products. The firm's responses outlining planned corrective actions were deemed insufficient due to a lack of provided documentation and revised plans. The FDA requires a written response within fifteen working days detailing specific corrective steps, including documentation, to prevent recurrence. Failure to comply may result in regulatory actions like seizure, injunction, or suspension of food facility registration, and re-inspection fees.