FDA Inspection
Mobius Imaging, LLCMobius Imaging, LLC – FDA Inspection, Apr 4, 2018
Record Details
This FDA Inspection record concerns Mobius Imaging, LLC, with an inspection on April 4, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b2b431c4-5154-4719-8d12-e7881f58fe6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046991
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Mobius Imaging, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Mobius Imaging, LLC
- FDA Inspection 938890 - 2015-06-30
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