FDA Inspection 813538 — Eisai, Inc.
The FDA completed an inspection of Eisai, Inc. on Jan 17, 2013 in Nutley, NJ. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 17, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Nutley, NJ (United States)
Additional details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |