In brief, the facility failed to set and maintain critical limits for temperature control. The storage coolers for mollusks and pasteurized crab meat did not have proper temperature settings. The
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/euro-usa-inc-666173-11222023
Euro USA Inc
MARCS-CMS 666173 — NOVEMBER 22, 2023
receiving CCP for the Combined Molluscan Shellfish HACCP plan that includes reduced oxygen packaged shucked raw, scallops in cans, lists a critical limit that fails to ensure the products were held at adequate temperatures continuously during transit to your facility. The CP for the Scombroid fish HACCP plan, lists a critical limit that is not adequate to control histamine formation.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/euro-usa-inc-666173-11222023
Euro USA Inc
MARCS-CMS 666173 — NOVEMBER 22, 2023