FDA WARNING_LETTER - Ostrea d.o.o. - July 10, 2014

The FDA inspected Ostrea d.o.o.'s seafood processing facility in Stankovci, Croatia, on July 9-10, 2014, identifying violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Although the firm responded to the FDA 483, a revised HACCP plan was not provided. The FDA noted that the firm intends to ship products to the U.S. soon and must correct all deviations prior to doing so. Failure to comply renders fish or fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specifically, scombroid species like sardine, mackerel, and tuna products are considered adulterated due to potential scombrotoxin (histamine) formation from improper handling. The significant deviations include: 1) Failure to conduct a proper hazard analysis and have a HACCP plan listing critical control points for scombroid species to control histamine formation, as required by 21 CFR 123.6(a) and (c)(2). The firm's plan lacked critical control points for processing steps under unrefrigerated conditions. 2) Failure to have a HACCP plan listing critical limits at the receiving critical control point for scombroid species to control histamine formation, as required by 21 CFR 123.6(c)(3). The plan lacked critical limits for receiving fresh fish, which were observed to be received without proper chilling. Ostrea d.o.o. must provide a revised HACCP plan and five consecutive days of monitoring records to demonstrate compliance. Failure to adequately respond may lead to refusal of admission for imported products under Section 801(a) of the Act, including detention without physical examination (DWPE) via Import Alert #16-120, and re-inspection fees under Section 743. The firm is responsible for ensuring full compliance with all applicable regulations.