FDA 483 - Catalent Belgium SA - July 07, 2017

An FDA inspection of Catalent Belgium, SA in Brussels, Belgium, revealed several significant deficiencies in their manufacturing and quality control processes. The firm failed to thoroughly investigate discrepancies and out-of-specification results, and lacked adequate validation for sterilization processes. Other issues included unauthorized access to labeling materials, insufficient environmental monitoring, and poor equipment maintenance, indicating a need for improved quality systems.