FDA 483 - Parnell Manufacturing Pty, Ltd. - September 17, 2024

Parnell Manufacturing Pty, Ltd. in Alexandria, Australia, a sterile drug manufacturer, received four observations during an FDA inspection. The observations highlight inadequate validation of sterilization processes, deficiencies in cleaning and disinfection procedures for sterile processing areas, and failures in investigating unexplained discrepancies and batch failures. These issues collectively indicate potential risks to product sterility and overall quality control.