FDA WARNING_LETTER - Husain, Mustafa M, M.D. - March 07, 2008

This FDA Warning Letter, dated September 10, 2008, informs Dr. Mustafa M. Husain of serious violations identified during an inspection of his clinical site from March 4-7, 2008. The inspection assessed compliance with 21 CFR Part 50 (Protection of Human Subjects) and Part 812 (Investigational Device Exemptions) for the clinical study [redacted] Investigational Device Exemption (IDE) [redacted], involving a [redacted] device.

Violations include: 1. **Failure to conduct the investigation according to the signed agreement, investigational plan, and applicable FDA regulations** (21 CFR 812.100 and 812.110(b)). Specifically, subjects [redacted] and [redacted] did not complete the protocol-required [redacted] period of [redacted] days, which could decrease the [redacted] threshold and result in prolonged [redacted]. Dr. Husain's response acknowledging the deviation was deemed inadequate as it lacked documentation of corrective or preventative actions. 2. **Failure to maintain accurate, complete, and current records and submit required reports** (21 CFR 812.140(a)(1), 812.140(a)(2)(i)(iii), 812.150(a)(