FDA Inspection 974401 — Eisai Manufacturing Limited
The FDA completed an inspection of Eisai Manufacturing Limited on May 13, 2016 in Hatfield. 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
- May 13, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hatfield (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |