SGS FranceAugust 29, 2025

FDA 483 - SGS France - August 29, 2025

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Record Details

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.

Company: SGS France
Inspection Date: August 29, 2025
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Ruben C. Ayala (investigator)
Xingfang Li

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ID · 6edc34f4-69ed-480c-abd7-a70c0cb64de4