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

Source: https://www.keypedia.com/records/483/antaria-pty-ltd/015dff38-0a4c-4431-b66d-6fa4d7b20275

> FDA 483 for Antaria Pty., Ltd. on November 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Antaria Pty., Ltd.
- Inspection Date: 2023-11-13
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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.

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## Related Officers

- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/antaria-pty-ltd/8b7ee174-61ea-4d5a-87cf-fc6c17334edf

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3