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

Source: https://www.globalkeysolutions.net/records/483/laboratoires-kabs-inc/a21ed79f-c7a2-43bb-81c5-a0a6c96a3b3c

> FDA 483 for Laboratoires KABS Inc. on January 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratoires KABS Inc.
- Inspection Date: 2024-01-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)
- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/laboratoires-kabs-inc/f7c92d6d-8dda-46eb-b2f7-9a65b3ab82cb

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