KeraCure, Inc. – FDA Warning Letter, May 7, 2008

This FDA Warning Letter to KeraCure, Inc., dated August 20, 2008, details objectionable conditions observed during an inspection from April 8 to May 7, 2008, regarding their participation in a clinical study involving an investigational device. The inspection aimed to ensure data validity, accuracy, and human subject protection.

The letter identifies several violations of 21 CFR Part 812 - Investigational Device Exemptions:

1. **Failure to report unanticipated adverse device effects (UADE) promptly:** KeraCure failed to submit complete, accurate, and timely UADE reports to the FDA, IRBs, and investigators within 10 working days. Specific examples include delays of over two months and 30 days for various subjects' adverse events, and a complete lack of documentation for other UADE reports.

2. **Failure to secure investigator compliance or terminate participation:** KeraCure did not promptly secure compliance from non-compliant investigators or discontinue device shipments and terminate their participation, even after discovering protocol violations at multiple sites. Examples include continued device shipments despite documented enrollment and protocol deviations, and delays in closing non-compliant sites for over a year.

3. **Failure to ensure proper monitoring:** KeraCure failed to follow its monitoring plan, specifically regarding on-site visit reports, follow-up activities, and corrective actions. Instances include follow-up letters omitting documented protocol deviations and