FDA Inspection 1041308 — Eisai, Inc.
The FDA completed an inspection of Eisai, Inc. on Feb 16, 2018 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 16, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Nutley, NJ (United States)
Additional details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |