FDA 483 - Lonza Walkersville, Inc. - June 09, 2016

Lonza Walkersville, Inc., a licensed LAL manufacturer in Walkersville, MD, was cited for inadequate corrective actions regarding sterility failures, with multiple instances of gram-positive organism contamination. Additionally, the inspection revealed insufficient control over packaging and labeling operations, which led to mix-ups of endotoxin vials in LAL kits and subsequent Biological Product Deviation Reports. These findings indicate significant issues in quality control and manufacturing processes.