During an inspection of a Portuguese seafood processor in Portugal, the FDA identified serious HACCP Violations for which it issued a 483. Among the violations were:
- Incomplete Hazard Analysis that did not identify Staph. aureus as a potential hazard in certain products.
- Improper critical limit for temperature control to manage the hazard of Staph. aureus and histamine.
- GMP violations included incomplete sanitation since sanitizing was not performed after cleaning steps.
Although the processor responded to FDA with revisions to its HACCP plans for canned tuna and canned sardine products with monitoring records, FDA deemed the revisions to be inadequate and issued a warning letter.
Because the processor imports its products to the US, inadequacy of its further response and corrective actions to the violations in the warning letter could be cause for refusal for admission of its imported fish or fishery products, including placing them on detention without physical examination (DWPE).
