Redbeast Enterprises Inc dba High Quality Research – FDA 483, Jul 26, 2021
Redbeast Enterprises Inc dba High Quality Research in Fort Collins, CO, a nonclinical laboratory, received a Form 483 with five observations. The inspection revealed significant deficiencies in final study report documentation, including missing signed reports, descriptions of data integrity impacts, and personnel names. Additionally, the firm lacked adequate standard operating procedures for laboratory methods and failed to ensure proper training and experience for personnel involved in nonclinical studies.
- Inspection date
- July 26, 2021
- Product type
- other
- Office
- Denver District Office
- Person
ID · 09b926cc-5ddf-47fb-a872-9c159b4a26b1
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.