FDA WARNING_LETTER - Pingdingshan Tianjing Plant Albumen Co., Ltd. - August 17, 2023

On April 17, 2024, the FDA issued a Warning Letter to Mr. Yan Wang, following an inspection of their facility in Pingdingshan, Henan, China, from August 15 to 17, 2023. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117) concerning their ready-to-eat (RTE) Soy Protein Isolate.

The FDA determined the RTE Soy Protein Isolate was adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations included:

1. **Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):** * Failure to identify recontamination with environmental pathogens (e.g., Salmonella) as a hazard requiring a preventive control for RTE Soy Protein Isolate, which is exposed to the environment post-lethal treatment. * Inadequate sanitation controls: observed soy protein residue on food-contact surfaces (scoop, filling spout, air removal probes) after documented cleaning. * Ineffective sanitization method (UV light for 5 minutes) and use of a vacuum for cleaning post-lethal treatment surfaces. * Environmental monitoring program deficiencies: no documentation