FDA WARNING_LETTER - Replidyne, Inc. - October 17, 2006

This Warning Letter, dated January 18, 2008, informs Replidyne, Inc. of objectionable conditions found during FDA investigations between July 2006 and October 2006, concerning their role as the applicant for NDA [redacted] for the drug [redacted]. The FDA's Bioresearch Monitoring Program aims to ensure research conduct, human subject protection, and data validity.

Replidyne acquired rights to clinical investigations sponsored by [redacted] (conducted 2000-2003) and submitted a marketing application on December 20, 2005. The FDA identified two key deficiencies:

1. **Failure to make underlying raw data available for FDA audit [21 CFR 314.3(b)]**: Replidyne failed to provide all raw data. Examples include inability to obtain SOPs from [redacted], missing monitoring visit reports for Protocol [redacted] Clinical Site #36, and inability to locate or access records for two international clinical investigators (Dr. [redacted] and Dr. [redacted]). The FDA emphasized Replidyne's responsibility, as the applicant, to ensure all underlying raw data was available prior to submission.

2. **Failure to provide adequate descriptions and analyses of relevant safety and effectiveness data [21 CFR 314.50(d)(5)(iv)]**: Replidyne submitted