FDA Inspection
OndaMed IncOndaMed Inc – FDA Inspection, Aug 15, 2016
Record Details
This FDA Inspection record concerns OndaMed Inc, with an inspection on August 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OndaMed Inc
- Inspection Date
- August 15, 2016
- Product Type
- Devices
View Company Profile
ID · 10f3baf8-1177-4a70-91e2-a5966d5221ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986755
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OndaMed Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2018 | 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 1067339 - 2018-09-28
- FDA Inspection 938468 - 2015-08-17
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