FDA WARNING_LETTER - Guangzhou Sinocon Food Co., Ltd. - March 19, 2024

On March 18-19, 2024, the FDA inspected Guangzhou Sinocon Food Co., Ltd.'s facility in China, focusing on their ready-to-eat (RTE) Oat Beta Glucan powder. The inspection revealed a serious violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

The primary violation was the failure to appropriately identify and evaluate recontamination with environmental pathogens, specifically Salmonella, as a hazard requiring a preventive control at the post-sterilization (b)(4) step, where product is exposed to the environment. The company's hazard analysis, dated July 9, 2022, did not identify this as a hazard requiring a preventive control, despite the product not receiving a subsequent lethal treatment.

Additionally, the company was found to be issuing inaccurate Certificates of Analysis (COAs) for finished product lots (e.g., SF-OG70-240227, SF-OG70-240203, SF-OG70-240122) indicating negative Salmonella and S. aureus test results, even when these tests had not been performed, violating 21 CFR 117.305(b) and (d) regarding accurate record-keeping. Furthermore, the firm did not conduct environmental monitoring for Salmonella or an appropriate