FDA 483 - TRS Labs Inc. - April 22, 2022

This FDA Form 483 report details observations made at TRS Labs Inc., a nonclinical laboratory in Athens, GA. The inspection revealed significant deficiencies in the firm's quality assurance unit, standard operating procedures, and record-keeping practices. Issues include failure to follow and review SOPs, lack of proper documentation for equipment maintenance and water testing, and inadequate oversight by the quality assurance unit.