Fisk Seafood in Iceland has not yet resolved all of its issues with the U.S. Food and Drug Administration. FDA inspected the seafood processing facility on Sept. 12 and 13, 2016, finding serious violations of the U.S. seafood Hazard Analysis and Critical Control Point (HACCP) regulations.

FDA issued a Form-483 report on its inspection observations and Fisk Seafood on Oct. 4 responded by email with documentation and photographs of its corrective actions. However, in a warning letter dated Jan. 11, FDA informed Fisk Seafood that those measures were “not adequate.” The letter gives Fisk Seafood 15 additional working days to make further required corrections.

Until corrected, FDA said the company’s individually quick frozen, cooked and peeled shrimp products are considered to be adulterated because they’ve been prepared, packed or held under conditions that are injurious to health.

The FDA warning letter outlines three areas where it continues to find “significant deviations” at Fisk.

The first involves the requirement that the company conduct a hazard analysis for each kind of fish and fishery product it produces to determine the food safety hazards that are likely to occur. Specifically, FDA is concerned about the hazard of C. botulinum toxin formation in connection with frozen shrimp at Fisk.

Second, FDA says Fisk must have a HACCP plan that at a minimum lists critical limits that must be met. Maintaining temperatures and reducing pathogen levels are among those limits.

Finally, the agency cited the company for failing to monitor and document sanitation along with improper labeling. FDA says Fish must keep complete sets of records.

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