# FDA 483 - Nico de Vries, M.D. - August 09, 2013

Source: https://www.keypedia.com/records/483/nico-de-vries-md/109fdc1a-4f17-4202-8127-799490fa890b

> FDA 483 for Nico de Vries, M.D. on August 09, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nico de Vries, M.D.
- Inspection Date: 2013-08-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Nico de Vries, M.D., Principal Investigator, in Amsterdam, revealed significant deficiencies in the conduct of a clinical study. Key issues included inaccurate and incomplete adverse event records, as well as improper and outdated informed consent documentation. These findings indicate a failure to adequately protect subject rights and welfare, and to adhere to the investigational plan.

## Related Officers

- [Manager, Data Science and Engineering](https://www.keypedia.com/people/kelly-d-moore/a5778f12-e968-4fc9-8391-b2cb5753232a)

Company: https://www.keypedia.com/companies/nico-de-vries-md/7c4dc318-3953-4f85-92be-f414003d4e9a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd