FDA Inspection 1075048 — Eisai Company Ltd.
The FDA completed an inspection of Eisai Company Ltd. on Dec 21, 2018 in Kakamigahara. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 21, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kakamigahara (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |