FDA 483 - Jiangsu Tohope Pharmaceutical Co., Ltd. - August 31, 2018

An FDA inspection of JIANGSU TOHOPE PHARMACEUTICAL CO., LTD. in CHANGCHUN CITY, JIANGSU, CHINA, identified a significant issue with quality control procedures. The firm failed to ensure proper calibration entries for a pH meter used in the testing of Alpha Lipoic Acid, indicating a lapse in instrument control and record-keeping. This suggests a moderate severity issue related to quality system deficiencies.