FDA Inspection
Monteris Medical CorpMonteris Medical Corp – FDA Inspection, Oct 4, 2018
Record Details
This FDA Inspection record concerns Monteris Medical Corp, with an inspection on October 4, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0de5bdae-c573-409c-804e-ae61398fc745
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067866
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design validation - user needs and intended uses
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Other FDA inspections of Monteris Medical Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Monteris Medical Corp
- FDA Inspection 983042 - 2016-06-30
- FDA Inspection 910131 - 2014-11-14
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