FDA 483 - Nantong Chanyoo Pharmatech Co., Ltd. - March 22, 2019

An FDA inspection of Nantong Chanyoo Pharmatech Co., LTD, an API manufacturer in Nantong, Jiangsu Province, revealed significant deficiencies. Observations included inadequate equipment maintenance and calibration, lack of proper preventative maintenance procedures, and poor facility repair. Additionally, the firm's material system and inventory records were found to be inaccurate.