FDA Inspection 1018565 — Siemens Healthcare Diagnostics, Inc.
The FDA completed an inspection of Siemens Healthcare Diagnostics, Inc. on May 12, 2017 in East Walpole, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- East Walpole, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |