740641
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 15, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mansfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |