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483
•Frei, Donald MD•November 1, 2018

Frei, Donald MD – FDA 483, Nov 1, 2018

Record Details

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.

Company
Frei, Donald MD
Inspection date
November 1, 2018
Product type
drugs
Office
Denver District Office
Person
  • Jonathan R. Campos
View Company Profile

ID · def1bbe7-8077-45c1-9ccf-ac5e032317d0

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