FDA Inspection 1109519 — Sumika Chemical Analysis Service, Ltd.
The FDA completed an inspection of Sumika Chemical Analysis Service, Ltd. on November 13, 2019 in Oita. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oita (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |