FDA 483 - P.D.E.A.'s Ayurved Rugnalaya & Sterling Multispeciality Hospital - February 16, 2023

An FDA inspection of P.D.E.A.'s Ayurved Rugnalay & Sterling Multispeciality Hospital in Pune, India, revealed significant failures in conducting foreign clinical studies according to good clinical practices. The facility did not maintain adequate and accurate case histories and records for a bioavailability/bioequivalence study, exhibiting numerous data integrity issues and missing documentation. Additionally, an untoward medical occurrence was not reported as an adverse event, indicating serious deficiencies in clinical trial oversight.