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

Source: https://www.keypedia.com/records/warning_letter/antaria-pty-ltd/504f0b7d-a513-43e1-a3df-95873551c33f

> FDA WARNING_LETTER for Antaria Pty. Ltd. on November 17, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Antaria Pty. Ltd.
- Inspection Date: 2023-11-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Lois A. Kotkoskie](https://www.keypedia.com/people/lois-a-kotkoskie/14b131ee-fff5-4d1c-bd77-2c7b95fce1a6)
- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Daniel W. Brisker](https://www.keypedia.com/people/daniel-w-brisker/62ffbf38-994e-4901-8639-3b2b130c67f2)

Company: https://www.keypedia.com/companies/antaria-pty-ltd/75a35309-1252-400a-8df6-8fc50814952f

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c