FDA WARNING_LETTER - Panjin Hetian Food Co., Ltd. - December 03, 2020

On July 7, 2021, the FDA issued a Warning Letter to Haba Village, Ping’an Town, Dawa Xian Panjin Shi Liaoning Sheng, China, following an inspection of their rice protein powder facility from December 1-3, 2020. 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).

The primary violation cited was the failure to identify and evaluate environmental pathogens, specifically Salmonella, as a known or reasonably foreseeable hazard for ready-to-eat (RTE) rice protein powder, which is exposed to the environment prior to packaging. The FDA noted that the firm's environmental monitoring procedures were inadequate, using TPC and coliforms, which are not appropriate indicator organisms for environmental pathogens. Additionally, the cleaning of food-contact surfaces involved a cold water wash without detergent, and the firm's response regarding revised cleaning procedures was unclear on scope and sanitization. The FDA emphasized that water in a dry processing environment increases Salmonella risk and that wet cleaning should be carefully controlled and include sanitizer.

Further violations included the failure to identify bacterial pathogens like Salmonella in raw materials as a foreseeable hazard. Although the firm identified steam dryers as a critical control point for moisture, monitoring records showed inaccurate temperature readings and a broken gauge that was not addressed.

The FDA requested a written response within fifteen working days outlining specific corrective