FDA Inspection
Intuitive Imaging Informatics LLCIntuitive Imaging Informatics LLC – FDA Inspection, Jul 26, 2018
Record Details
This FDA Inspection record concerns Intuitive Imaging Informatics LLC, with an inspection on July 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · 820e2214-4ac9-42d3-8fb8-de9566cf30f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061600
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Intuitive Imaging Informatics LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 2, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 19, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Intuitive Imaging Informatics LLC
- FDA Inspection 1148417 - 2021-08-06
- FDA Inspection 912235 - 2015-02-02
- FDA Inspection 735294 - 2011-07-19
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