# FDA 483 - Mark Dacey, M.D. - November 08, 2024

Source: https://www.keypedia.com/records/483/mark-dacey-md/2cd18e95-9104-4701-ba2c-6c015d8daff6

> FDA 483 for Mark Dacey, M.D. on November 08, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mark Dacey, M.D.
- Inspection Date: 2024-11-08
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Mark S. Dacey, M.D. in Denver, CO, was cited for significant deficiencies in clinical investigation practices, primarily concerning informed consent, adherence to investigational plans, and the maintenance of accurate case histories. The inspection revealed multiple instances where subjects were not properly consented, and protocols were not followed. Data discrepancies were prevalent, indicating a serious lack of oversight in clinical trial conduct.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/mark-dacey-md/ed7742ad-3e38-4cea-81b6-04efbb2010e8

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face