New Life Corporation – FDA Warning Letter, Jun 7, 2012

This Warning Letter to New Life Corporation, dated June 7, 2012, addresses serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) for their Mahi Mahi Fresco products. The FDA reviewed the firm's March 23, 2012, HACCP plan and receiving records, finding the scombrotoxin-forming fish adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan failed to list undeclared allergens as a significant hazard. 2. **Critical Limits (21 CFR 123.6(c)(3)):** The plan lacked a critical limit for decomposition during sensory evaluation at the Receiving critical control point. 3. **Monitoring Procedures and Frequency (21 CFR 123.6(c)(4)):** * **Process CCP:** Monitoring for histamine control was inadequate; it specified internal temperature measurement instead of ambient air temperature for unrefrigerated exposure. * **Storage CCP:** Monitoring for ice adequacy and cooler temperature was inadequate, specifying internal temperature and visual observation instead of continuous temperature recording. 4. **Corrective Actions (21 CFR 1