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483
•Air Liquide Canada Inc.•March 13, 2020

Air Liquide Canada Inc. – FDA 483, Mar 13, 2020

Record Details

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.

Company
Air Liquide Canada Inc.
Inspection date
March 13, 2020
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Yasamin Ameri (Compliance Officer)
View Company Profile

ID · 431d3f92-b797-44c9-8415-5f2aa366ade4

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