FDA WARNING_LETTER - Sardina d.o.o. - July 18, 2014

On March 4, 2015, the FDA issued a Warning Letter to Sardina d.o.o. following an inspection of their seafood processing facility in Postira, Croatia, on July 17-18, 2014. The inspection revealed serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), resulting in an FDA-483.

The FDA deemed the firm's responses inadequate. The primary violation was the failure to have and implement a compliant HACCP plan, rendering their scombroid species products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific deficiencies included: - **Inadequate Critical Control Points (CCPs):** The HACCP plan for fresh and frozen scombroid species did not list CCPs for controlling scombrotoxin (histamine) formation during thawing, storage of fresh fish, and cumulative exposure times to unrefrigerated conditions during processing (e.g., brining, rinsing, evisceration, pasteurizing, cooling, and retort operations before reaching 60°C). The FDA recommended a cumulative unrefrigerated processing time not exceeding 12 hours. - **Inadequate Critical Limits:** The critical limit of "melting ice temperature" at the "Receipt of Fresh and Frozen Fish" CCP was insufficient for fresh fish.