FDA WARNING_LETTER - Nauta, Haring J.W., MD - February 14, 2008

This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Haring J. W. Nauta's clinical site from February 12-14, 2008. The inspection assessed compliance with federal regulations for the clinical study titled [redacted], under IDE [redacted], sponsored by [redacted].

Key violations include: 1. **Failure to ensure informed consent (21 CFR 50.20 and 50.27(a)):** Two subjects signed an unapproved, substantially different 2-page consent form instead of the IRB-approved 4-page version. Another subject signed a form lacking the IRB approval stamp. 2. **Failure to conduct investigation in accordance with protocol and regulations (21 CFR 812.100 and 812.110(b)):** * Failure to perform required follow-up visits and procedures for multiple subjects as per protocol, despite sponsor notification to continue follow-up. * Failure to record required [redacted] and [redacted] evaluations on CRFs for several subjects. * Enrollment of a subject with an exclusion criterion ([redacted]). * Failure to record and report a post-operative complication and surgery for a subject on the correct CRF. * Continued study follow-up after IRB approval lapsed on February 28, 20