FDA Inspection 1115467 — Hospira, Inc.
The FDA completed an inspection of Hospira, Inc. on January 17, 2020 in Mcpherson, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 17, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mcpherson, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |