FDA Inspection
Mobius Medical Systems, LPMobius Medical Systems, LP – FDA Inspection, Jun 7, 2018
Record Details
This FDA Inspection record concerns Mobius Medical Systems, LP, with an inspection on June 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f8beab0f-eb5c-4396-929f-65f695eac33c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054723
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
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Other FDA inspections of Mobius Medical Systems, LP
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 29, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mobius Medical Systems, LP
- FDA Inspection 984864 - 2016-08-29
- FDA Inspection 783032 - 2012-05-29
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