FDA WARNING_LETTER - Yangpo Foods Co.,Ltd. - April 27, 2012

On April 26-27, 2012, the FDA inspected Yangpo Foods Co., Ltd., a seafood manufacturing facility in Pohang, Korea, and found deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123). The firm's canned mackerel and mackerel-pike in brine were deemed adulterated under 21 U.S.C. § 342(a)(4) due to preparation, packing, or holding conditions that could render them injurious to health.

Key violations include: 1. **Inadequate HACCP Plans (21 CFR 123.6(c)(2))**: The plans lacked appropriate critical control points (CCPs) for histamine formation. This included failing to distinguish between primary and secondary processing for receiving fresh fish, omitting sensory evaluation and internal temperature monitoring for primary processing, and not assessing conditions during transit for secondary processing. Additionally, CCPs for time and temperature exposures during processing (thawing, cutting, etc.) were missing, potentially exceeding recommended cumulative exposure times for histamine development. 2. **Insufficient Critical Limits (21 CFR 123.6(c)(3))**: HACCP plans lacked adequate critical limits for histamine control at receiving and thawing CCPs. Specifically, no critical limit for sensory evaluation and internal temperature was listed for raw material receiving of canned mackerel, and no critical limit for decomposition for canned