FDA WARNING_LETTER - Mostel, Edward, M.D. - October 31, 2007

On October 17-31, 2007, the FDA conducted an investigation at Palm Beach Gardens Medical Center, reviewing Dr. Edward Mostel's conduct of Protocol [redacted] as part of the Bioresearch Monitoring Program. The inspection revealed non-adherence to FDA regulations governing clinical investigations and human subject protection.

Key violations include: 1. **Failure to obtain informed consent prior to drug administration (21 CFR 50.20):** Two subjects received study drug one to two days before their Informed Consent Documents (ICDs) were signed by both the subject and the investigator. The response attributing this to dating errors was deemed unacceptable due to lack of verification. 2. **Failure to maintain adequate drug disposition records (21 CFR 312.62(a)):** Drug accountability records were missing for nine subjects. The claim that hospital records confirmed drug receipt lacked supporting evidence. 3. **Failure to conduct the study according to the investigational plan (21 CFR 312.60):** * One subject's ICD was not signed or dated by the Principal Investigator or Sub-investigator, contrary to protocol requirements. * One subject was enrolled twice into the study, despite the protocol excluding subjects with prior enrollment. The investigator acknowledged this sub-investigator error but retained responsibility. 4. **Failure to maintain adequate and accurate case histories (