FDA WARNING_LETTER - Synapse Biomedical Inc. - March 18, 2008

This Warning Letter to Synapse Biomedical Inc. details objectionable conditions observed during an FDA inspection from February 25 to March 18, 2008, concerning their clinical studies for the [redacted] device. The inspection aimed to ensure compliance with federal regulations, scientific validity of data, and protection of human subjects.

Serious violations of 21 CFR Part 812—Investigational Device Exemptions were identified. Key violations include: 1. **Failure to obtain FDA approval prior to allowing subjects to participate (21 CFR 812.42):** Synapse Biomedical Inc. began an investigation by enrolling subjects and expanding to four additional clinical sites without prior FDA approval. Their response was inadequate, lacking a corrective and preventive action plan. 2. **Failure to ensure adequate monitoring of the investigation (21 CFR 812.40):** Monitoring was inadequate and not in accordance with their SOP. Examples include missing documentation for monitoring of 16 subjects, uncorrected omissions in monitoring visit reports (e.g., missing lab tests, discrepancies in data), and incorrect IDE numbers in reports. The company's response was incomplete, lacking documentation of SOP implementation or training, and a plan for verifying historical data. The monitoring SOP also failed to address protocol deviations. 3. **Failure to obtain signed financial disclosure agreements from investigators (21 CFR 812.43(c)(5)):**