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Warning Letter

HACCP, GMP, FSP Violations Trigger Warning Letter

A facility which processes seafood and acidified foods recently received a warning letter that followed observations from a 2023 inspection which included failure to provide a scheduled process for its acidified foods along with Seafood HACCP, GMP, and FSP violations.

Specifically, the facility:

  • Did not provide a scheduled process to the FDA for its acidified foods thermal processing, including information about the heat processing and pH, salt, sugar and preservative levels and demonstration that this was established by a qualified person. Additionally, the processing was not supervised by a person who had attended an FDA-approved course.
  • Did not follow the Seafood HACCP Plan monitoring procedures.
  • Did not have a written Food Safety Plan for covered products.
    • Had numerous GMP violations, including inadequate hand hygiene; unsanitary facility conditions evidenced by accumulated soil above the filling areas, clutter, and condensation dripping onto food contact sites; lack of a bathroom in the facility; inadequate cleaning of nonfood contact areas; poor maintenance of grounds; and flying insects in the facility.
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