FDA Inspection 977950 — Eisai Inc.
The FDA completed an inspection of Eisai Inc. on Jul 22, 2016 in Baltimore, MD. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |