FDA WARNING_LETTER - Hunan Gagazui Food Co., Ltd. - November 23, 2023

On February 9, 2024, the FDA issued a Warning Letter to Sanfeng Industrial Park, Huarong Xian, Yueyang Shi, Hunan Sheng, China, following an inspection from November 20-23, 2023. The inspection revealed serious deviations from the Emergency Permit Control (21 CFR Part 108) and Low Acid Canned Foods (21 CFR Part 113) regulations. The firm failed to respond to the FDA-483 issued at the inspection's conclusion.

Key violations include: 1. Processing food not in conformity with the filed scheduled process (21 CFR 108.35(c)(3)(i)), specifically for their (b)(4) brand 22g Surimi Soybean Snack (Spicy Flavor). This involved different time/temperature processing, inadequate heat distribution study support, and failure to document initial product temperature. 2. Retorts lacking accurate temperature-recording devices (21 CFR 113.40(b)(2)). 3. Processing and production forms omitting required data such as product variety, container count, initial temperature, and device readings (21 CFR 113.100(a)). 4. Failure to use heat-sensitive indicators on retort baskets (21 CFR 113.87(b)). 5. Inadequate identification codes on herm