FDA Inspection
Atcor Medical Pty Ltd.Atcor Medical Pty Ltd. – FDA Inspection, Aug 13, 2015
Record Details
This FDA Inspection record concerns Atcor Medical Pty Ltd., with an inspection on August 13, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Atcor Medical Pty Ltd.
- Inspection Date
- August 13, 2015
- Product Type
- Devices
View Company Profile
ID · bd51f5b6-892e-4cf2-8fa1-4fae8988cea6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943982
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Atcor Medical Pty Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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