FDA Inspection 1039547 — Hospira, Inc.
The FDA completed an inspection of Hospira, Inc. on February 2, 2018 in Rocky Mount, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rocky Mount, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |
| 3696 | 21 CFR 820.100(b) | Documentation |