FDA WARNING_LETTER - O'Barr, Thomas Jr., M.D. - September 30, 2009

This FDA Warning Letter, dated September 30, 2010, was issued to Thomas O'Barr, Jr., M.D., following an inspection conducted between September 16 and 30, 2009. The inspection, part of the Bioresearch Monitoring Program, reviewed Dr. O'Barr's conduct of clinical investigations for the investigational drug (b)(4) under Protocols (b)(4) and (b)(4) for (b)(4).

The FDA concluded that Dr. O'Barr failed to adhere to statutory requirements and FDA regulations governing clinical investigations. Key violations include:

1. **Failure to ensure investigation conducted according to investigational plan [21 CFR 312.60]:** Dr. O'Barr failed to maintain all study records as required by Protocol (b)(4). Specifically, case report forms for 20 screened and 10 enrolled subjects, and source documents for Subject 500010, were unavailable. Dr. O'Barr's reliance on study coordinators was deemed unacceptable, as the ultimate responsibility lies with the clinical investigator.

2. **Failure to maintain adequate and accurate case histories [21 CFR 312.62(b)]:** For Protocol (b)(4), discrepancies were noted. For Subject 500006, a Clinically Significant Abnormal Lab Values form indicated no significant abnormalities, contradicting