FDA Inspection
Foresight Imaging, LLCForesight Imaging, LLC – FDA Inspection, Apr 20, 2010
Record Details
This FDA Inspection record concerns Foresight Imaging, LLC, with an inspection on April 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Foresight Imaging, LLC
- Inspection Date
- April 20, 2010
- Product Type
- Devices
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ID · ac082a51-3df3-438c-afe6-2982d63f1ebb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658431
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.72(b)(2)Calibration documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Foresight Imaging, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2025 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| December 20, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Foresight Imaging, LLC
- FDA Inspection 1294938 - 2025-12-12
- FDA Inspection 1194465 - 2022-12-20
- FDA Inspection 1023886 - 2017-08-29
- FDA Inspection 810782 - 2012-12-12
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