FDA Inspection 1061378 — Nippon Shikizai, Inc.
The FDA completed an inspection of Nippon Shikizai, Inc. on Aug 3, 2018 in Zama. 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
- Aug 3, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zama (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |