FDA 483 - Shanghai InnoStar Bio-tech Co., Ltd. - May 22, 2018

The FDA inspected Nat'lShanghaiCtr for NewDrug Safety Eval.&Research(InnoStar), a non-clinical testing facility in Shanghai, China, and issued a Form 483 with nine observations. The findings indicate significant deficiencies in Good Laboratory Practice (GLP) regulations, including issues with raw data retention, quality assurance oversight, test and control article handling, animal care, and archive management. These observations suggest a systemic lack of adherence to established procedures and regulatory requirements for nonclinical studies.