FDA 483 - SGS France - August 29, 2025

During an inspection from August 25 to August 29, 2025, the FDA identified several significant procedural and documentation failures at SGS France Life Sciences, a bioanalytical facility located in Saint Benoit, France. The inspection uncovered that the facility utilized an analytical method that lacked sufficient specificity, leading to consistent interference in samples that was never resolved. Additionally, the facility failed to disclose rejected analytical runs in its final validation and study reports, omitting critical details regarding equipment failures, reconstitution errors, and sample carryover. Documentation practices were also found to be substandard; laboratory technicians routinely typed and pasted sample preparation steps into records after experiments were completed, leading to inconsistencies and casting doubt on the accuracy of the data. Furthermore, management failed to follow established Standard Operating Procedures by overturning run rejection decisions without documenting the necessary deviations. These observations were issued under Section 704(b) of the Food, Drug, and Cosmetic Act. While these findings are not a final determination of compliance, the company is expected to respond. SGS France Life Sciences must either discuss its corrective action plans with the FDA representatives or submit a formal written response to the FDA headquarters addressing how it will rectify these analytical and record-keeping deficiencies.