FDA Inspection
ZONARE Medical Systems, Inc.ZONARE Medical Systems, Inc. – FDA Inspection, Jul 28, 2011
Record Details
This FDA Inspection record concerns ZONARE Medical Systems, Inc., with an inspection on July 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZONARE Medical Systems, Inc.
- Inspection Date
- July 28, 2011
- Product Type
- Devices
View Company Profile
ID · ad8cbb1c-c9f3-407e-90be-581bdc405cd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 739039
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ZONARE Medical Systems, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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