FDA WARNING_LETTER - Gordon, Stephen W., MD - February 12, 2008

This Warning Letter details objectionable conditions observed during an FDA inspection of Stephen W. Gordon, MD's clinical site from January 22 to February 12, 2008. The inspection assessed compliance with federal regulations for clinical studies titled [redacted] under IDE [redacted], sponsored by [redacted]. This inspection also aimed to verify corrective actions promised after violations in a 2003 FDA inspection.

The inspection revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include:

1. **Failure to ensure informed consent (21 CFR 812.100, 21 CFR 50.20, 21 CFR 50.27(a))**: * Subject [redacted] signed a consent form for the incorrect study, using an outdated form with incorrect IRB information. * Subject [redacted] underwent a procedure before signing the consent form, with no documentation of prior verbal consent.

2. **Failure to conduct investigation in accordance with sponsor agreement, investigational plan, and regulations (21 CFR 812.100, 21 CFR 812.110(b))**: * No documentation that previously enrolled subjects received an IRB-required informed consent attachment with updated IRB information,