FDA 483 - Peet John J MD - July 16, 2024

An FDA inspection of John J. Peet, M.D., Clinical Investigator in The Woodlands, TX, revealed significant non-compliance with clinical study protocols and record-keeping. The firm failed to conduct the investigation according to the plan, delegated duties to unqualified personnel, and maintained inadequate investigational drug disposition records. Additionally, issues were noted with maintaining accurate case histories and ensuring proper informed consent documentation, indicating serious concerns regarding data integrity and subject safety.