FDA 483 - Antaria Pty., Ltd. - July 21, 2025

Antaria Pty. Ltd., an API and drug manufacturer in Rocklea, Australia, received a Form 483 with 12 observations highlighting severe deficiencies across its quality system. Key issues include inadequate quality unit oversight, widespread failures in OOS investigations, lack of process validation, insufficient raw material testing, poor data integrity controls for computerized systems, and untimely annual product reviews. These deficiencies indicate a systemic breakdown in ensuring product quality, safety, and efficacy.