FDA 483 - SGS France - August 29, 2025

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.