Arna Pharma Pty Ltd — FDA Facility Profile
Arna Pharma Pty Ltd is an FDA-registered facility (FEI 3007428662) located in Frenchs Forest, AU. Registered operations: ANALYSIS; MANUFACTURE; PACK. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 17, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (4 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 17, 2025 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Computer control of master formula records (21 CFR 211.68(b)) Investigations of discrepancies, failures (21 CFR 211.192) |
| May 17, 2019 | Voluntary Action Indicated (VAI) | Computer control of master formula records (21 CFR 211.68(b)) |
| Sep 21, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 16, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- ARNA Pharma Pty., Ltd.
- Location
- Frenchs Forest (AU)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; MANUFACTURE; PACK
- Source
- decrs