FDA 483 - ClinSync Clinical Research Pvt Ltd

An FDA inspection of ClinSync Clinical Research Pvt. Ltd. in Hyderabad, India, on January 10-13, 2020, revealed a significant issue regarding the retention of reserve samples. The firm failed to retain representative reserve samples of investigational product from multiple shipments used in studies submitted to the FDA. Additionally, there were discrepancies in the documentation of product shipments in clinical study reports.