FDA EIR - Tapan Padhya, M.D. - August 08, 2024

An FDA surveillance inspection of Clinical Investigator Tapan Padhya, M.D., in Tampa, FL, occurred from August 6 to August 8, 2024. This routine, pre-market inspection, conducted under the Bioresearch Monitoring program, focused on a clinical trial involving an investigational medical device. The review encompassed study administration, protocols, IRB documentation, subject records, financial disclosures, and investigational product controls for a study that screened 19 subjects, with two enrolled. While no FDA Form 483 was issued, a key issue was identified regarding Informed Consent Forms (ICFs). Specifically, two ICFs for one subject lacked the doctor's printed name, another ICF for a different subject was missing the printed name, and one ICF was signed by the Clinical Investigator three months after the subject consented. These issues highlight deficiencies in proper and timely documentation of informed consent, which is crucial for human subject protection under the Federal Food, Drug, and Cosmetic Act. Dr. Padhya acknowledged these findings and committed to ensuring correct completion of ICFs in the future. Although the Agency recommended 'No Action Indicated' for this inspection, verbal warnings were provided regarding potential regulatory actions if future violations occur.