FDA Inspection
Deerfield Imaging, Inc.Deerfield Imaging, Inc. – FDA Inspection, Jan 26, 2018
Record Details
This FDA Inspection record concerns Deerfield Imaging, Inc., with an inspection on January 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5c75e86-572d-46e7-ac62-37ccc4c42d12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038905
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Deerfield Imaging, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 1, 2019 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| February 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Deerfield Imaging, Inc.
- FDA Inspection 1106208 - 2019-10-01
- FDA Inspection 913223 - 2015-02-04
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