FDA Inspection 1163970 — Siemens Healthcare Diagnostics, Inc.
The FDA completed an inspection of Siemens Healthcare Diagnostics, Inc. on March 8, 2022 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- East Walpole, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |