FDA 483 - Synchron Research Services Pvt. Ltd. - November 22, 2019

An FDA inspection of Synchron Research Services Pvt. Ltd., a Contract Research Organization in Ahmedabad, India, revealed significant issues with incomplete and inaccurate study documentation. Specifically, discrepancies were found in the recording of sample receipt and storage details, including dates, locations, temperatures, and times. These findings indicate a moderate severity of non-compliance related to data integrity and record-keeping practices.