FDA Inspection
Go Medical Industries Pty., Ltd.Go Medical Industries Pty., Ltd. – FDA Inspection, Sep 14, 2011
Record Details
This FDA Inspection record concerns Go Medical Industries Pty., Ltd., with an inspection on September 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 14, 2011
- Product Type
- Devices
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ID · 402b0a1a-e87a-4481-91ff-6031d02d7b55
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 749478
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Go Medical Industries Pty., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 21, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Go Medical Industries Pty., Ltd.
- FDA Inspection 1258046 - 2024-12-10
- FDA Inspection 1014898 - 2017-06-21
- FDA Inspection 917407 - 2015-02-18
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