FDA Inspection 860646 — Eisai Inc.
The FDA completed an inspection of Eisai Inc. on Dec 17, 2013 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4576 | 21 CFR 211.192 | No written record of investigation |