FDA Inspection
Atcor Medical Pty Ltd.Atcor Medical Pty Ltd. – FDA Inspection, Oct 20, 2011
Record Details
This FDA Inspection record concerns Atcor Medical Pty Ltd., with an inspection on October 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Atcor Medical Pty Ltd.
- Inspection Date
- October 20, 2011
- Product Type
- Devices
View Company Profile
ID · 96af72dc-2b3b-41ba-a840-4233e8a49cb5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 751185
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Atcor Medical Pty Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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