FDA Inspection
MODULATED IMAGING, INC.MODULATED IMAGING, INC. – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns MODULATED IMAGING, INC., with an inspection on May 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8dc662d8-e170-45fa-9057-bdaab48049c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091039
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MODULATED IMAGING, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MODULATED IMAGING, INC.
- FDA Inspection 1238578 - 2024-05-07
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