FDA 483 - Xinyu Pharmaceutical Co., Ltd. - March 11, 2019

Xinyu Pharmaceutical Co., Ltd. in Suzhou, China, was inspected from March 11-15, 2019, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate change control for API quality, insufficient documentation practices for stability data, and a deficient system for maintaining and calibrating critical equipment. Additionally, the validation of GMP-related computerized systems was found to be inadequate.