# FDA 483 - Robin Cornelissen - April 08, 2022

Source: https://www.keypedia.com/records/483/robin-cornelissen/df50166f-3712-44af-aa10-d70c3d0eca30

> FDA 483 for Robin Cornelissen on April 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robin Cornelissen
- Inspection Date: 2022-04-08
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: During an inspection from April 4-8, 2022, the FDA observed that Robin Cornelissen, MD, a Principal Investigator in Rotterdam, Netherlands, failed to maintain accurate case histories. Specifically, the firm did not report numerous adverse events documented in subjects' source records for a clinical protocol. This indicates a significant lapse in clinical trial record-keeping and adverse event reporting.

## Related Officers

- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.keypedia.com/companies/robin-cornelissen/10992748-f06b-439a-a9e3-704d18186786

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4