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

Source: https://www.keypedia.com/records/warning_letter/guangzhou-sinocon-food-co-ltd/72812122-233a-47a5-8a16-25df761dbee4

> FDA WARNING_LETTER for Guangzhou Sinocon Food Co., Ltd. on March 19, 2024. Product: Other. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Guangzhou Sinocon Food Co., Ltd.
- Inspection Date: 2024-03-19
- Product Type: Other
- Office Name: Human Foods Program
- Summary: 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

## Related Officers

- [Maria S. Knirk](https://www.keypedia.com/people/maria-s-knirk/e6e2f9cd-19a3-4ccf-91f3-c9f86daadba5)

Company: https://www.keypedia.com/companies/guangzhou-sinocon-food-co-ltd/1729db30-ba39-4c43-8808-c98023e90166

Office: https://www.keypedia.com/offices/human-foods-program/8bff4a0b-7bed-449c-b67b-56a83c96a324