# FDA 483 - SGS North America Inc. - January 10, 2023

Source: https://www.keypedia.com/records/483/sgs-north-america-inc/000b766b-dc49-4a46-af69-dbe0803890a2

> FDA 483 for SGS North America Inc. on January 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SGS North America Inc.
- Inspection Date: 2023-01-10
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of SGS North America Inc., a control testing laboratory in Lincolnshire, IL, revealed a significant failure in thoroughly reviewing unexplained discrepancies and ensuring equipment meets specifications. Specifically, the firm did not properly assess the impact of an out-of-tolerance micropipette and lacked documentation for returning it to service after it was tagged out. This indicates deficiencies in their investigation and equipment management procedures.

## Related Documents

- [EIR - 2019-04-24](https://www.keypedia.com/records/eir/sgs-north-america-inc/2ed0c86d-2d1e-4b9d-a595-0d172055aefe)
- [483 - 2026-03-20](https://www.keypedia.com/records/483/sgs-north-america-inc/eaa78b6f-c64f-4dc6-9e78-12e6c071b4f9)

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-p-diorio/fba94f6f-38b9-4d30-b8a1-d6c9d4769e49)

Company: https://www.keypedia.com/companies/sgs-north-america-inc/720655d2-660d-4355-81b5-bf1fb4da0a89

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669