SyntheMed Inc – FDA Warning Letter, Oct 26, 2007

On February 19, 2008, the FDA issued a Warning Letter to SyntheMed Inc. following an inspection from October 9-26, 2007, regarding their clinical study of [redacted], a medical device. The inspection revealed serious violations of 21 CFR Part 812 – Investigational Device Exemption.

Key violations include: 1. **Failure to secure investigator compliance (21 CFR 812.46(a)):** SyntheMed failed to ensure investigators adhered to the protocol, specifically regarding masked assessments. At sites [redacted] and [redacted], the same physicians performed both [redacted] and [redacted] assessments, unmasking randomization. There was no documentation of sponsor approval, IRB notification, or monitoring notation of these deviations. SyntheMed's response was inadequate, lacking a written corrective plan, training documentation, and policies for managing non-compliant investigators. 2. **Failure to ensure adequate monitoring and written monitoring procedures (21 CFR 812.40, 812.25(e)):** SyntheMed did not consistently [redacted] after monitoring visits, and when they did, protocol deviations were not identified. For example, Site [redacted] had unmasked assessments, but no [redacted] was documented. SyntheMed's response was insufficient, lacking training documentation and corrective actions for