# FDA 483 - SGS France - August 29, 2025

Source: https://www.globalkeysolutions.net/records/483/sgs-france/6edc34f4-69ed-480c-abd7-a70c0cb64de4

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of SGS France Life Sciences in Saint Benoit, France, revealed significant deficiencies in their bioanalytical facility's method validation and study sample activities. Observations included an analytical method lacking sufficient specificity, incomplete reporting of rejected analytical sequences, and non-contemporaneous documentation of experiments. Additionally, the firm failed to follow established SOPs regarding deviation documentation, indicating systemic issues with data integrity and quality control.

## Related Officers

- [Xingfang Li, MD, RAC, Pharmacologist](https://www.globalkeysolutions.net/people/xingfang-li-md-rac-pharmacologist/90c790ce-68fd-4bfb-b6bc-38e02d63f11e)
- [Ruben C. Ayala, PharmD, Lead Pharmacokineticist](https://www.globalkeysolutions.net/people/ruben-c-ayala-pharmd-lead-pharmacokineticist/7f55123e-b6ff-41bb-9865-98357aab636a)
- [investigator](https://www.globalkeysolutions.net/people/ruben-c-ayala/6b5dadad-56b8-4af0-a65f-4685f71f0c8d)
- [Xingfang Li](https://www.globalkeysolutions.net/people/xingfang-li/ba1d0660-b34d-4acf-bd63-e5c7c9c2f8cb)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd