FDA Inspection 1265006 — MP Biomedicals Asia Pacific Pte Ltd
The FDA completed an inspection of MP Biomedicals Asia Pacific Pte Ltd on March 21, 2025 in Singapore. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |