FDA 483 - Laboratoires KABS Inc. - January 25, 2024

An FDA inspection of Laboratoires KABS Inc. in Val-Des-Sources revealed significant deficiencies in their quality systems for both human drug and medical device manufacturing. Observations included a lack of written quality control unit procedures and inadequate cleaning process qualification for drug manufacturing equipment. Additionally, the firm failed to adequately validate an assembly machine for medical devices and did not properly verify the effectiveness of corrective and preventive actions.