FDA Inspection
Caliber Imaging and Diagnostics, Inc.Caliber Imaging and Diagnostics, Inc. – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns Caliber Imaging and Diagnostics, Inc., with an inspection on June 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5c43c57e-d71c-49d0-9017-0cb8855ed8fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012817
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Caliber Imaging and Diagnostics, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2025 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| April 18, 2022 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 10, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 7, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Caliber Imaging and Diagnostics, Inc.
- FDA Inspection 1260155 - 2025-02-06
- FDA Inspection 1167844 - 2022-04-18
- FDA Inspection 1106559 - 2019-10-10
- FDA Inspection 618535 - 2009-08-07
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