# FDA 483 - ARNA Pharma Pty., Ltd. - October 17, 2025

Source: https://www.keypedia.com/records/483/arna-pharma-pty-ltd/9f4587d4-f80f-4882-a81c-89dcd010f781

> FDA 483 for ARNA Pharma Pty., Ltd. on October 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARNA Pharma Pty., Ltd.
- Inspection Date: 2025-10-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of ARNA Pharma Pty., Ltd. in Frenchs Forest, Australia, revealed significant deficiencies in quality control and data integrity. The firm failed to thoroughly investigate out-of-specification results and implement corrective actions, and lacked appropriate controls over computer systems and written procedures for the quality control unit. These issues indicate a serious breakdown in the firm's quality management system.

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Paranthaman SenthamaraiKannan](https://www.keypedia.com/people/paranthaman-senthamaraikannan/8e592c88-299c-4fe5-b408-45880e6ae728)

Company: https://www.keypedia.com/companies/arna-pharma-pty-ltd/e06145c8-ecf7-4bc1-9e0d-5aab8615b08f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8