Warning letter
Hospira Australia Pty Ltd.: warning letter of Sep 26, 2014
FDA warning letter 432259 · Center for Drug Evaluation and Research
Key facts
| Reference number | 432259 |
|---|---|
| Company | Hospira Australia Pty Ltd. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 26, 2014 |
| Posted date | Oct 7, 2014 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.42(c)(10)(iv), 211.100(a) |
| Inspection city | Mulgrave |
| Inspection start date | Feb 24, 2014 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: