# FDA 483 - Frei, Donald MD - November 01, 2018

Source: https://www.keypedia.com/records/483/frei-donald-md/def1bbe7-8077-45c1-9ccf-ac5e032317d0

> FDA 483 for Frei, Donald MD on November 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Frei, Donald MD
- Inspection Date: 2018-11-01
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Frei F. Donald MD, a clinical investigator in Englewood, CO, revealed a significant deficiency in informed consent practices. The firm failed to include required statements regarding confidentiality of records and the possibility of FDA inspection in informed consent documents for subjects in the ATLAS study. This indicates a failure to ensure all basic elements of informed consent were present.

## Related Officers

- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

Company: https://www.keypedia.com/companies/frei-donald-md/32cd22f0-073b-4adf-a778-7beee32f19f8

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