FDA Inspection 1250099 — OSTEOPORE INTERNATIONAL PTE LTD
The FDA completed an inspection of OSTEOPORE INTERNATIONAL PTE LTD on Sep 26, 2024 in Singapore. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 26, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |