FDA Inspection 954715 — Nebraska Methodist Hospital
The FDA completed an inspection of Nebraska Methodist Hospital on Dec 18, 2015 in Omaha, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 18, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |