FDA 483 - Canadian Analytical Laboratories Inc. - March 03, 2020

Canadian Analytical Laboratories Inc., a contract testing laboratory in Mississauga, was inspected by the FDA and received a Form 483 with five observations. The observations primarily highlight significant deficiencies in data integrity, computer system controls, data backup, and the validation and suitability verification of analytical test methods. These issues indicate a lack of robust quality control and data management practices within the laboratory.