846920
Siemens Healthcare Diagnostics Inc — FEI 3002637618
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 21, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Norwood, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |