814255
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beverly, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 5007 | 21 CFR 1002.13 | Failure to submit |