# FDA 483 - SGS France - August 29, 2025

Source: https://www.keypedia.com/records/483/sgs-france/3d3aaae2-7ca6-46ab-9d49-4857f803c24f

> FDA 483 for SGS France on August 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SGS France
- Inspection Date: 2025-08-29
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: SGS France Life Sciences, a bioanalytical facility in Saint Benoît, France, was inspected by the FDA. The inspection revealed significant issues with analytical method validation, including a lack of specificity for a chiral method and inadequate documentation of rejected analytical runs. Additionally, the firm failed to contemporaneously document method validation experiments and did not follow established SOPs regarding deviation documentation.

## Related Documents

- [483 - 2025-08-29](https://www.keypedia.com/records/483/sgs-france/6edc34f4-69ed-480c-abd7-a70c0cb64de4)
- [483 - 2025-08-29](https://www.keypedia.com/records/483/sgs-france/6a76b690-1ef4-450c-b603-188b97a515c8)

## Related Officers

- [Xingfang Li](https://www.keypedia.com/people/xingfang-li/ba1d0660-b34d-4acf-bd63-e5c7c9c2f8cb)
- [investigator](https://www.keypedia.com/people/ruben-c-ayala/6b5dadad-56b8-4af0-a65f-4685f71f0c8d)

Company: https://www.keypedia.com/companies/sgs-france/1fb1371f-b96f-40bf-9b23-1a4b8aa24809

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4