FDA 483 - Antaria Pty., Ltd. - November 13, 2023

An FDA inspection of Antaria Pty Ltd, an API and drug manufacturer in Rocklea, Queensland, Australia, from November 13-17, 2023, revealed significant deficiencies across its quality system and laboratory operations. The firm failed to adequately investigate out-of-specification results, maintain complete laboratory records, and implement a robust stability testing program. These issues indicate a lack of adherence to fundamental good manufacturing practices.