FDA Inspection 1192063 — Nippon Kayaku Pharmatech Co., Ltd.
The FDA completed an inspection of Nippon Kayaku Pharmatech Co., Ltd. on Nov 25, 2022 in Toyama. 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 25, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Toyama (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |