FDA Inspection 584951 — Hospira Inc
The FDA completed an inspection of Hospira Inc on May 22, 2009 in Morgan Hill, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 22, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Morgan Hill, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3300 | 21 CFR 820.100(a)(1) | Statistical methodology |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |