FDA 483 - Kaysersberg Pharmaceuticals SAS - July 07, 2023

Kaysersberg Pharmaceuticals S.A.S., a contract manufacturer in Kaysersberg, France, was inspected by the FDA. The inspection revealed significant deficiencies in establishing the accuracy, sensitivity, and reproducibility of test methods. Additionally, the firm failed to exercise appropriate controls over computer systems, leading to concerns regarding data integrity and unauthorized changes to records.