FDA 483 - Redbeast Enterprises Inc dba High Quality Research - July 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.