FDA 483 - Guangxi Wuzhou Changhong Food Co., Ltd. - February 21, 2025

The FDA inspection of Guangxi Wuzhou Changhong Food Co., Ltd. revealed critical deficiencies in their thermal processing and food safety management for herbal jelly products. Issues included inadequate temperature recording, improper water levels during processing, and a lack of essential heat distribution data and initial temperature verification. The firm also lacked a comprehensive food safety plan, proper processing record review, and qualified personnel for thermal processing operations, indicating significant regulatory non-compliance and potential product safety risks.