FDA WARNING_LETTER - Antaria Pty. Ltd. - November 17, 2023

The FDA inspected Antaria Pty. Ltd. (FEI 3025978151) in Rocklea, Queensland, Australia, from November 13-17, 2023, identifying significant Current Good Manufacturing Practice (CGMP) deviations for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Inadequate OOS Investigations:** Failure to properly investigate and document out-of-specification (OOS) results for assay and loss on ignition (LOI), with OOS lots released. The firm's response cited staff turnover and training issues but lacked a holistic review of investigations, customer notification for OOS lots, or retrospective assessment of retain samples. 2. **Insufficient Analytical Testing:** Failure to perform assay and LOI testing of (b)(4) USP according to current USP monographs or provide data supporting method equivalence. 3. **Incomplete Laboratory Records:** Lack of complete data in laboratory records, including preparation details for solutions, diluents, mobile phases, reagents, and documentation of instruments/equipment used. The firm's response was inadequate as it didn't address overall traceability or a comprehensive strategy to confirm the validity of previous analytical data. 4. **Deficient Stability Testing Program:** Failure to conduct an adequate, ongoing stability testing program, specifically not placing at least one API lot manufactured in 2019, 2020