Company
AustraliaPolynovo Biomaterials Pty Ltd., Port Melbourne, Australia – FDA Inspections
Inspection records and compliance data for Polynovo Biomaterials Pty Ltd. in Port Melbourne. 1 FDA inspection on record, 1 Form 483, last inspected October 19, 2017.
Company Profile
This profile covers Polynovo Biomaterials Pty Ltd. based in Port Melbourne, Australia.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected October 19, 2017.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design validation - production units1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 19, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1029183 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Polynovo Biomaterials Pty Ltd.
FEI Number
3007886187
Address
U 2 320 Lorimer St, Port Melbourne, Australia
Country
Australia
ID: f8241508-a4c7-44a5-b7f9-1e7f1dc59270