# FDA 483 - Caitlin C. Meyer, M.D. - December 21, 2022

Source: https://www.keypedia.com/records/483/caitlin-c-meyer-md/33116e50-c260-4dd0-8f1f-2099ae314885

> FDA 483 for Caitlin C. Meyer, M.D. on December 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Caitlin C. Meyer, M.D.
- Inspection Date: 2022-12-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Caitlin C. Meyer, M.D., a clinical investigator in North Miami, FL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures in obtaining proper informed consent, maintaining adequate subject case histories, and adhering to the investigational plan, including timely reporting of a serious adverse event. These issues indicate a lack of control over critical aspects of clinical trial management and subject protection.

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/caitlin-c-meyer-md/6e4f16a7-902d-44f3-a36d-56ffb58b8748

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6