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

Source: https://www.keypedia.com/records/483/air-liquide-canada-inc/431d3f92-b797-44c9-8415-5f2aa366ade4

> FDA 483 for Air Liquide Canada Inc. on March 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Air Liquide Canada Inc.
- Inspection Date: 2020-03-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.keypedia.com/companies/air-liquide-canada-inc/016d17f6-1b4d-44d8-aad0-506bc0cab5b1

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1