FDA 483 - Kaysersberg Pharmaceuticals SAS - July 19, 2016

Kaysersberg Pharmaceuticals SAS, a drug manufacturer in Kaysersberg, France, was cited for multiple deficiencies during an FDA inspection. Key issues include inadequate investigations into discrepancies, insufficient environmental monitoring in aseptic areas, and failures in sanitation, cleaning, calibration, and process control procedures. The observations indicate a lack of robust quality systems and process validation.