FDA Inspection
Signature Orthopedics Pty LimitedSignature Orthopedics Pty Limited – FDA Inspection, Jul 5, 2018
Record Details
This FDA Inspection record concerns Signature Orthopedics Pty Limited, with an inspection on July 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5bdd4f42-6715-4667-b7ba-6f252d390ab8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1058816
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of Signature Orthopedics Pty Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Signature Orthopedics Pty Limited
- FDA Inspection 840802 - 2013-06-27
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