Company
AustraliaSignature Orthopedics Pty Limited, Lane Cove West, Australia – FDA Inspections
Inspection records and compliance data for Signature Orthopedics Pty Limited in Lane Cove West. 2 FDA inspections on record, 1 Form 483, last inspected July 05, 2018.
Company Profile
This profile covers Signature Orthopedics Pty Limited based in Lane Cove West, Australia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 27, 2013. Last inspected July 5, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
- Remedial action1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 5, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1058816 |
| June 27, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 840802 |
FDA documents
Form 483s (2)
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Company Information
Name
Signature Orthopedics Pty Limited
FEI Number
3008262872
Address
Lane Cove W, 7 Sirius Rd, Lane Cove West, Australia
Country
Australia
ID: 684f8207-f340-40aa-9137-9f618a93cc92