FDA 483 - Yangzhou H&R Plastic Daily Chemical Co., Ltd. - October 31, 2025

An FDA inspection of Changzhou Qianhong Bio-Pharma Co., Ltd., an API manufacturer in Changzhou, China, revealed a significant failure to establish and document specifications for raw materials, intermediates, and APIs. Specifically, the firm did not define or verify hold time limits for materials and intermediates, impacting the quality of API batches distributed to the U.S. market. This indicates a serious lapse in quality control and assurance.