FDA WARNING_LETTER - Kemal Balikcilik Ihracat - September 14, 2021

On January 12, 2022, the FDA issued a Warning Letter to Mr. Ahmet Tuncay Sagun, owner of a seafood processing facility in Urla, Izmir, Turkey (Reference # 618729). This letter followed a Foreign Remote Regulatory Assessment (FRRA) conducted from September 7-14, 2021, due to COVID-19 travel restrictions.

The FDA identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's Tuna, Seabass, Seabream, Salmon, Trout, and Anchovy products were deemed adulterated under 21 U.S.C. § 342(a)(4) because they were prepared, packed, or held under conditions that may render them injurious to health.

Key violations include: - Failure to conduct a proper hazard analysis and implement adequate HACCP plans as required by 21 CFR 123.6(a) and (c)(2). - HACCP plans for aquaculture seabass, seabream, salmon, trout, and anchovy products did not list receiving as a critical control point to control aquaculture drugs, despite identifying the hazard. - HACCP plans for tuna and anchovy products lacked critical control points for receiving, processing, and refrigerated storage to control scombrotoxin (histamine) formation.