FDA 483 - Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd. - May 21, 2021

The FDA inspected Jiangsu Sihuan Bioengineering Pharmaceutical Co., Ltd., a drug manufacturer, and issued a Form 483 with five observations. Significant issues were identified concerning data integrity, including missing electronic raw data and inadequate backup procedures for laboratory instruments. Additionally, the firm lacked appropriate controls over computerized systems, failed to establish scientifically sound test procedures for impurities, and did not properly qualify essential manufacturing equipment or implement adequate change control procedures.