FDA Inspection
OndaMed IncOndaMed Inc – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns OndaMed Inc, with an inspection on September 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a9c51805-ec82-4916-abaf-df1b4f7966b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067339
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(b)(2)Reports and information documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OndaMed Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OndaMed Inc
- FDA Inspection 986755 - 2016-08-15
- FDA Inspection 938468 - 2015-08-17
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