FDA EIR - Redbeast Enterprises Inc dba High Quality Research - July 26, 2021

An FDA inspection of High Quality Research, a nonclinical laboratory in Fort Collins, CO, was conducted from July 21-26, 2021. This high-priority inspection focused on Good Laboratory Practice (GLP) compliance, pursuant to the Center for Veterinary Medicine's ADUFA compliance program. During the inspection, five significant observations were cited on an FDA Form 483. These included failures related to the final study report: specifically, the omission of signed and dated reports from contributing scientists, a description of circumstances potentially affecting data quality, and the names of all involved professionals, particularly concerning a contracted third-party laboratory. Additionally, the company lacked written standard operating procedures for critical nonclinical laboratory methods, such as blood collection and processing. Finally, deficiencies were noted in ensuring that all personnel engaged in nonclinical laboratory studies had the necessary training and experience to perform assigned functions, particularly for animal care technicians involved in blood sample processing. The regulatory framework for this inspection was 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, under the Federal Food, Drug, and Cosmetic Act. Management acknowledged the observations and committed to providing a written response within 15 business days. They were also advised of potential enforcement actions, including regulatory meetings, warning letters, or facility disqualification, should compliance not be achieved.