FDA 483 - Ryan M. Rich, M.D. - July 29, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Ryan M. Rich, M.D., a clinical investigator in Colorado Springs, CO, revealed significant deficiencies in the conduct of an investigational study. The firm failed to follow the investigational plan, including enrolling an ineligible subject and allowing unmasked personnel to perform safety assessments. Additionally, the inspection found a failure to maintain adequate and accurate case histories, with numerous instances of source records being changed without justification.
- Office
- Denver District Office
- Person
ID · 5ff13a24-74ce-42af-a038-5141c6856704