FDA Inspection 658431 — Foresight Imaging, LLC
The FDA completed an inspection of Foresight Imaging, LLC on Apr 20, 2010 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 20, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |