FDA WARNING_LETTER - Yantai Shanhai Foodstuff Co., Ltd - September 23, 2014

On September 22-23, 2014, the FDA inspected Yantai Shanhai Foodstuff Co., Ltd. in China, identifying violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's October 15, 2014, response, including revised HACCP plans for frozen mackerel fillet/piece, frozen, breaded fish fillet/piece, and frozen crab flesh, was deemed inadequate, particularly lacking a revised plan for frozen, vinegar-soaked mackerel pieces.

The FDA found continuing serious deviations, rendering products like frozen, vinegar-soaked mackerel pieces, frozen crab flesh, and frozen mackerel fillet/piece adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plans (21 CFR 123.6(a) and (c)(2)):** * The HACCP plan for frozen, vinegar-soaked mackerel pieces lacked a critical control point (CCP) for processing to control scombrotoxin (histamine) formation during extended soaking. * Revised HACCP plans for frozen mackerel fillet/piece and frozen crab flesh, and the plan for frozen, vinegar-soaked mackerel pieces, failed to list CCPs for: * Thawing of raw materials (m