Hospira Australia Pty Ltd — FDA Facility Profile
Hospira Australia Pty Ltd is an FDA-registered facility (FEI 3001174929) located in Mulgrave, AU. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Sep 2, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (1 OAI, 2 VAI, 3 NAI)
- Last OAI inspection
- Mar 4, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 26, 2014
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 2, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 2, 2019 | No Action Indicated (NAI) | No citations listed |
| Sep 15, 2015 | No Action Indicated (NAI) | No citations listed |
| Mar 4, 2014 | Official Action Indicated (OAI) | Following/documenting laboratory controls (21 CFR 211.160(a)) Extent of discrepancy, failure investigations (21 CFR 211.192) Scientifically sound laboratory controls (21 CFR 211.160(b)) |
| Mar 21, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Aug 25, 2009 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Hospira Australia Pty Ltd.
- Location
- Mulgrave (AU)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs