Liaoning Taihong Biotechnology Co., Ltd.'s Pollock Fillets Added to U.S. FDA Import Alert Red List

On October 22, 2026, the U.S. Food and Drug Administration (FDA) updated Import Alert 16-120, adding Liaoning Taihong Biotechnology Co., Ltd. to the "Detention Without Physical Examination" (DWPE) red list. The product involved is refrigerated non-ready-to-eat raw salted pollock fillets (reduced oxygen packaged). The company's address is No. 31 Yongxiang West Street, Donggang City, Dandong, Liaoning Province.

The charge stated by the FDA reads: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a)." In plain terms: the product is subject to refusal of admission under Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act because it appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, and its processing appears to violate 21 CFR 123.6(a) and 123.8(a).

The product line listed for Liaoning Taihong on the red list is "16A--28 Pollack, Pollock" (pollock), with the product description "Refrigerated Non-Ready-to-Eat (nRTE) Raw Salted Pollock Fillets (Reduced Oxygen Packaged)." Its Notes (violation details) contain only two entries: "21 CFR 123.6(c)(1) - HACCP plan does not list the food safety hazards that are reasonably likely to occur"; and "21 CFR 123.6(c)(3) – Inadequate critical limits." That is: 21 CFR 123.6(c)(1) — the HACCP plan does not list the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) — inadequate critical limits.

The former (123.6(c)(1)) points to the first step of the HACCP system — a missing hazard analysis, meaning the company failed to identify hazards that may exist in the processing of salted pollock fillets, such as histamine, pathogenic bacteria, parasites, and unauthorized additives; the latter (123.6(c)(3)) is inadequate setting of critical limits. Together, the two indicate that this HACCP plan falls short at the two foundational stages of "identifying hazards — setting control limits," which is a systemic problem rather than a lapse in a single process step.

The full name of Import Alert 16-120 is "Detention Without Physical Examination of Fish and Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP Regulation," and it is used specifically to apply detention without physical examination to foreign processors that do not comply with the seafood HACCP regulation. Products from companies on the red list are detained upon entry into the United States without physical examination, and are released by customs only after passing testing by the FDA or an FDA-recognized laboratory and review and acceptance by the FDA's local office.

Salted pollock fillets, made from Alaska pollock, are a traditional processed category for the European and American markets. Liaoning and Shandong are China's main processing and export regions, and Donggang in Dandong is a particular cluster for processing enterprises using imported and supplied materials such as pollock and squid. Because reduced oxygen packaging (ROP) blocks oxygen, if not properly controlled it can inhibit aerobic spoilage bacteria while instead favoring the growth of anaerobic or facultative anaerobic pathogens such as Clostridium botulinum and Listeria, which is why the FDA's HACCP control requirements for this packaging format are particularly strict.

Liaoning Taihong's salted pollock fillets will henceforth be subject to detention without physical examination upon entry into the United States. This is the latest HACCP non-compliance notification in the pollock processing and export chain, and it is worth similar processing enterprises checking their own hazard analysis and critical limit settings against it.