FDA Inspection 1032011 — Daiichi Sankyo Co., Ltd. Hiratsuka Plant
The FDA completed an inspection of Daiichi Sankyo Co., Ltd. Hiratsuka Plant on Nov 2, 2017 in Hiratsuka. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 2, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hiratsuka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |