Warning letter
Hospira Inc.: warning letter of May 9, 2013
FDA warning letter 394420 · Chicago District Office
Key facts
| Reference number | 394420 |
|---|---|
| Company | Hospira Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 9, 2013 |
| Posted date | May 9, 2013 |
| Issuing office | Chicago District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 803.17(a)(3), 803.52(b)(2), 820, 820.40 |
| Inspection city | Lake Forest |
| Inspection ZIP | 60045 |
| Inspection start date | Jan 29, 2013 |
| 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: