FDA 483 - Air Liquide Canada Inc. - March 13, 2020

Air Liquide Canada Inc., a medical gas manufacturer in Hamilton, was cited for significant deficiencies across its quality system. The inspection revealed a lack of an independent Quality Control Unit, inadequate procedures for quality and batch record review, and failures in equipment qualification and data backup. Additionally, the firm was found to have insufficient qualified personnel, deficient GMP training, and issues with instrument calibration and annual product reviews.