FDA 483 - CSL Behring (Australia) Pty Ltd - March 08, 2022

An FDA inspection of CSL Behring Australia Proprietary Ltd in Broadmeadows revealed significant deficiencies in laboratory controls, sterile manufacturing, and product testing. Observations included incomplete laboratory records with inadequate data review, failed disinfectant efficacy studies, and deficient analytical methods for detecting microorganisms in drug products. These findings indicate a lack of assurance in data integrity and product sterility.