With foods imported into the U.S. required to meet the same regulations as foods produced in the U.S., a seafood products importer was cited for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
The FDA warning letter stated that the importer did not ensure that the seafood items they imported were in compliance with Seafood HACCP. This includes ensuring that the hazards of parasites and aquaculture drugs are controlled, and extends to specific species-related hazards including histamine.
Because the importers hazard analysis was incomplete, the corrective actions related to these hazards were determined to be inadequate. Additionally, the records were incomplete because they were not signed or dated.
When importing foods into the U.S. it is critical that importers know which regulations are applicable to their products, understand the complete rule, and ensure full compliance.
Once a warning letter is issued, the cited business has a limited time to respond, after which FDA can take further action, including refusing admission of the imported product, placing the products or importer on “detention without physical examination,” seizing the product(s), and/or enjoining the firm from further violating the Act.
