FDA Inspection
Clarity Medical Systems IncClarity Medical Systems Inc – FDA Inspection, Jun 30, 2011
Record Details
This FDA Inspection record concerns Clarity Medical Systems Inc, with an inspection on June 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Clarity Medical Systems Inc
- Inspection Date
- June 30, 2011
- Product Type
- Devices
View Company Profile
ID · a6fde12c-f858-486b-9c65-3878fe3e9d27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730094
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Clarity Medical Systems Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 15, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Clarity Medical Systems Inc
- FDA Inspection 1004666 - 2017-03-17
- FDA Inspection 831573 - 2013-05-15
- FDA Inspection 794931 - 2012-07-20
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