# FDA 483 - Sara J Haug, M.D., Ph.D. - April 21, 2023

Source: https://www.keypedia.com/records/483/sara-j-haug-md-phd/19b46b1b-f4ac-493f-bbde-b7ca5f759a18

> FDA 483 for Sara J Haug, M.D., Ph.D. on April 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sara J Haug, M.D., Ph.D.
- Inspection Date: 2023-04-21
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Sara J Haug MD PhD, Clinical Investigator, in Durango, CO, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to investigational plans and protocols, including issues with patient monitoring, adverse event reporting, investigational product administration, and informed consent. Additionally, the inspection found failures in maintaining adequate and accurate case histories, indicating poor data integrity practices.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.keypedia.com/companies/sara-j-haug-md-phd/a7958ac5-9e3e-48e4-86fe-b122859ff160

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