FDA Inspection
priMED Medical Products Inc.priMED Medical Products Inc. – FDA Inspection, Dec 16, 2015
Record Details
This FDA Inspection record concerns priMED Medical Products Inc., with an inspection on December 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- priMED Medical Products Inc.
- Inspection Date
- December 16, 2015
- Product Type
- Devices
View Company Profile
ID · ee22335e-355a-491c-81e9-17b12d15b727
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953484
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of priMED Medical Products Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for priMED Medical Products Inc.
- FDA Inspection 836467 - 2013-05-23
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