SGS FranceAugust 29, 2025

FDA 483 - SGS France - August 29, 2025

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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.

Company: SGS France
Inspection Date: August 29, 2025
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Operations
People: Xingfang Li
Ruben C. Ayala (investigator)

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ID · 3d3aaae2-7ca6-46ab-9d49-4857f803c24f