FDA Inspection 1283264 — Nippon Shikizai, Inc.
The FDA completed an inspection of Nippon Shikizai, Inc. on Sep 12, 2025 in Tsukuba. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tsukuba (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |