FDA WARNING_LETTER - Hoffman, David C. D.D.S. - December 12, 2007

This FDA Warning Letter, dated December 12, 2007, addresses objectionable conditions observed during an FDA inspection of David C. Hoffman, D.D.S.'s clinical investigational site from November 11 to December 12, 2007. The inspection assessed compliance with federal regulations for a clinical study involving a redacted device.

Violations of 21 CFR Part 812 (Investigational Device Exemptions), Part 54 (Financial Disclosure by Clinical Investigators), and Section 520(g) of the Act were identified. Key deficiencies include:

1. **Failure to conduct investigation according to agreement, plan, and regulations (21 CFR 812.100 and 812.110(b)):** Numerous subjects missed required follow-up examinations as per the protocol. This was a repeat violation from a 2002 inspection, and previous corrective actions were deemed inadequate. 2. **Failure to maintain accurate, complete, and current subject records (21 CFR 812.140(a)(3)):** Redacted forms lacked device part/lot/serial numbers, and dates of redacted in various documents did not correspond. 3. **Failure to submit complete, accurate, and timely reports of unanticipated adverse device effects (21 CFR 812.150(a)(1)):** Adverse effect