A warning letter from FDA to the Royal Ice Cream Company

The FDA inspected Connecticut's Royal ice cream ready-to-eat (RTE) manufacturing facility from January 19 through February 22, 2022. The inspection exposed the presence of Listeria monocytogenes in environmental swabs collected during the inspection, and other GMP, Hazard Analysis, and Risk-Based Preventive Controls violations. One swab from the filler head contained Listeria monocytogenes. Listeria monocytogenes were also detected in the finished product. The results indicate inadequate control of pathogens. @ https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-ice-cream-company-inc-630433-07282022

 

 The Royal Ice Cream Company Inc. - 630433 - 07/28/2022
The Royal Ice Cream Company Inc. - 630433 - 07/28/2022

CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

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