FDA 483 - Yichang Sanxia Pharmaceutical Co., Ltd.

An FDA inspection of Yichang Sanxia Pharmaceutical Company, LTD, an Active Pharmaceutical Ingredient manufacturer, revealed deficiencies in quality assurance and documentation practices. The firm failed to assess stability for critical raw material changes and did not consistently follow good documentation practices for analytical records and incubation times. These observations indicate a need for improved quality system controls.