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

The FDA conducted an inspection of Parnell Manufacturing Pty, Ltd., a sterile drug manufacturer located in Alexandria, New South Wales, Australia, from September 9 to September 17, 2024. The inspection revealed several critical compliance issues under the Federal Food, Drug, and Cosmetic Act.

Key observations include inadequate validation of sterilization processes, specifically the lack of sufficient process simulations (media fills) under worst-case conditions to ensure sterility. Additionally, deficiencies were noted in the cleaning and disinfection protocols for maintaining sterile conditions, with the current procedures lacking detailed steps to prevent contamination. The inspection also highlighted failures in thoroughly investigating discrepancies and defects in product batches, with a specific instance where visual inspection defects were overlooked due to the batch not being intended for sale.

Furthermore, the cleaning and maintenance procedures for equipment were found lacking in detail, particularly in the validation of cleaning processes. The procedures did not adequately justify or evaluate sample site locations for cleaning validation, potentially compromising the cleanliness of non-dedicated equipment.

The FDA requires Parnell Manufacturing to address these issues promptly to ensure compliance with regulatory standards. This includes revising and validating sterilization and cleaning processes, enhancing investigation protocols for product discrepancies, and ensuring thorough documentation and justification in cleaning validation procedures. These actions are necessary to maintain product safety and quality, thereby protecting public health.