# FDA WARNING_LETTER - SyntheMed Inc - October 26, 2007

Source: https://www.keypedia.com/records/warning_letter/synthemed-inc/cf9e34a7-35fb-425d-a215-f1b69432924e

> FDA WARNING_LETTER for SyntheMed Inc on October 26, 2007. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: SyntheMed Inc
- Inspection Date: 2007-10-26
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-a-ulatowski/23498f67-5e0f-4b28-9039-ad64e2dd5b04)
- [Eli Pine](https://www.keypedia.com/people/eli-pine/260daa0c-c56f-4295-b927-1e17465d9dd1)

Company: https://www.keypedia.com/companies/synthemed-inc/d474349c-3aaa-455e-9bdc-48250afd2ebf

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7