FDA 483 - Redbeast Enterprises Inc dba High Quality Research - February 27, 2023
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Redbeast Enterprises Inc dba High Quality Research, a nonclinical laboratory in Fort Collins, CO, was cited for numerous violations of FDA Good Laboratory Practice (GLP) regulations during an inspection from February 14-27, 2023. The observations primarily concern deficiencies in quality assurance unit operations, study director responsibilities, record keeping, and personnel management. These issues indicate significant systemic problems in ensuring the integrity and reliability of nonclinical laboratory studies.
- Inspection Date
- February 27, 2023
- Product Type
- Other
- Office
- Denver District Office
- Person
ID · 11b12ff6-f0c0-4f40-8b09-749b932d632e