FDA Inspection 639034 — Hospira, Inc.
The FDA completed an inspection of Hospira, Inc. on January 19, 2010 in Rocky Mount, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rocky Mount, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3694 | 21 CFR 820.100(a)(6) | Dissemination of problem information |
| 537 | 21 CFR 820.70(a) | Production processes |
| 538 | 21 CFR 820.70(a) | Process control procedures |