ARNA Pharma Pty., Ltd.October 17, 2025

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

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Record Details

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.

Company: ARNA Pharma Pty., Ltd.
Inspection Date: October 17, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Paranthaman Senthamarai Kannan

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ID · 9f4587d4-f80f-4882-a81c-89dcd010f781