FDA Inspection 1222671 — BEONE MEDICINES USA, INC.
The FDA completed an inspection of BEONE MEDICINES USA, INC. on Nov 13, 2023 in San Carlos, CA. 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 13, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Carlos, CA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |