FDA 483 - Naveed Razzaque, MD - September 25, 2019

An FDA inspection of Naveed Razzaque, MD in Bridgeton, MO, revealed critical deficiencies in clinical trial conduct. The firm failed to maintain adequate and accurate case histories, including instances of falsified records and forged signatures, which severely compromised data integrity. Additionally, the investigation found a lack of proper oversight, leading to missed protocol procedures and significant delays in reporting adverse events and protocol deviations to the IRB, raising concerns about subject safety and study validity.