FDA 483 - Asim R. Piracha, M.D. - July 29, 2022

This FDA Form 483 was issued to Asim R. Piracha, M.D. in Jeffersonville, IN, following an inspection from July 26-29, 2022. The inspection revealed significant deficiencies in the conduct of an investigation, including failures to adhere to exclusion criteria, perform required assessments, and maintain continuous IRB approval. Additionally, the firm failed to prepare and submit complete and accurate reports of unanticipated adverse device effects to the sponsor within the specified timeframe.