FDA WARNING_LETTER - Accelerated Freeze Drying Co. Ltd. - December 13, 2013

On June 2, 2014, the FDA issued a Warning Letter to Accelerated Freeze Drying Co. Ltd. following an inspection from December 12-13, 2013, which revealed violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's freeze-dried shrimp products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The revised HACCP plan for "(b)(4)" freeze-dried shrimp lacks critical control points (CCPs) for pathogen growth and toxin formation. Specifically, it fails to include CCPs for processing phases III-V, where temperatures are between (b)(4), and cumulative exposure times should be limited to 1 hour above 26.7°C. Additionally, a CCP for "(b)(4)" the product in the IQF tunnel before entering the "(b)(4)" is missing, which is crucial for achieving the required moisture content. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** * The critical limit of "(b)(4)" at the "Batch Cooking