FDA WARNING_LETTER - Gardiziola, Gregory, D.O. - May 30, 2008

This FDA Warning Letter (Ref: 08-HFD-45-0802) dated September 3, 2008, addresses Gregory Gardziola, D.O., regarding a clinical investigation (protocol [redacted]) of investigational drugs [redacted]. An FDA inspection, conducted by Ms. Karen Kondas between May 9 and 30, 2008, reviewed Dr. Gardziola's conduct of the study from October 2003 to May 2006.

The inspection revealed three violations of FDA regulations: 1. **Failure to assure IRB continuing review and approval (21 CFR 312.66):** IRB approval for the study expired on October 7, 2005, and was not renewed until October 19, 2006. During this lapse, 16 subjects were screened, enrolled, or randomized, and research activities continued. 2. **Failure to obtain informed consent (21 CFR 312.60, 21 CFR 50.20, 21 CFR 50.27(a)):** Subject [redacted] signed a sub-study consent but not the main study informed consent document. 3. **Failure to retain records (21 CFR 312.62(c)):** A signed informed consent document