797857
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 12, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Burlington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |