# FDA 483 - SGS North America Inc. - August 01, 2023

Source: https://www.globalkeysolutions.net/records/483/sgs-north-america-inc/ddc0e297-f53a-480e-a0e6-6556ff06354b

> FDA 483 for SGS North America Inc. on August 01, 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: 2023-08-01
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: SGS North America Inc. in Fairfield, NJ, a control testing laboratory, was cited with two observations during an FDA inspection. The inspection revealed significant issues with data integrity and quality control, including the use of unvalidated Excel spreadsheets for critical analytical data calculations and failures in documenting data review and error corrections. These deficiencies indicate a lack of robust control over computer systems and the quality unit's procedures.

## Related Officers

- [Amal H Mariun](https://www.globalkeysolutions.net/people/amal-h-mariun/619db06d-b5de-4f59-940e-563321695be9)
- [Pharmacist | Consumer Safety Officer](https://www.globalkeysolutions.net/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)
- [investigator](https://www.globalkeysolutions.net/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.globalkeysolutions.net/companies/sgs-north-america-inc/2ab4b437-f0ec-4f38-a8bc-88a319e32f4d

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248