Company
AustraliaAtcor Medical Pty Ltd., West Ryde, Australia – FDA Inspections
Inspection records and compliance data for Atcor Medical Pty Ltd. in West Ryde. 2 FDA inspections on record, last inspected August 13, 2015.
Company Profile
This profile covers Atcor Medical Pty Ltd. based in West Ryde, Australia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected October 20, 2011. Last inspected August 13, 2015.
Most cited issue areas
- Design validation- Lack of or inadequate procedures2 inspections
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 13, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 943982 |
| October 20, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 751185 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Atcor Medical Pty Ltd.
FEI Number
3003339185
Address
West Ryde, U 11 1059-1063 Victoria Rd, West Ryde, Australia
Country
Australia
ID: f7f8c0db-c8de-406f-95d7-925c0a4bee40