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

Source: https://www.keypedia.com/records/warning_letter/nauta-haring-jw-md/8166be39-531c-42b5-bc3a-d05c65e50067

> FDA WARNING_LETTER for Nauta, Haring J.W., MD on February 14, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nauta, Haring J.W., MD
- Inspection Date: 2008-02-14
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

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Company: https://www.keypedia.com/companies/nauta-haring-jw-md/42be4eba-d3d0-4f86-8065-0b8a1ab6a470

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