# FDA 483 - Nancy A. Krywonis, M.D. - July 23, 2021

Source: https://www.globalkeysolutions.net/records/483/nancy-a-krywonis-md/8d7e2569-4dfc-4628-be99-ff8968c3a53a

> FDA 483 for Nancy A. Krywonis, M.D. on July 23, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nancy A. Krywonis, M.D.
- Inspection Date: 2021-07-23
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Nancy A. Krywonis, M.D. in Denver, CO, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to investigational plans, obtain proper informed consent, ensure IRB oversight for all research sites, and maintain adequate and accurate case histories. These issues indicate a lack of compliance with regulatory requirements for clinical trials.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)
- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/nancy-a-krywonis-md/33f24f5f-2177-4053-a287-e04169c3f943

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