FDA Inspection 1023886 — Foresight Imaging, LLC
The FDA completed an inspection of Foresight Imaging, LLC on Aug 29, 2017 in Chelmsford, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3266 | 21 CFR 820.86 | Acceptance status |