Shree Hospital – FDA 483, Oct 21, 2023

Shree Hospital, a biopharmaceutics clinical facility in Pune, India, was cited for significant deficiencies during a bioequivalence/bioavailability clinical study inspection. The inspection revealed failures to adhere to Good Clinical Practices, including issues with informed consent, multiple protocol deviations, inadequate record-keeping, and uncalibrated equipment used for processing pharmacokinetic samples. These findings indicate a serious lack of control over critical aspects of clinical trial conduct.