FDA Inspection 869582 — Hospira Australia Pty Ltd.
The FDA completed an inspection of Hospira Australia Pty Ltd. on March 4, 2014 in Mulgrave. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 4, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mulgrave (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |