FDA Inspection 1329094 — Bushu Pharmaceuticals Ltd.
The FDA completed an inspection of Bushu Pharmaceuticals Ltd. on Aug 3, 2026 in Kawagoe. 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). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 3, 2026
- Fiscal Year
- 2026
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Kawagoe (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |