Company
AustraliaAdvanced Surgical Design & Manufacture, Ltd., St Leonards, Australia – FDA Inspections
Inspection records and compliance data for Advanced Surgical Design & Manufacture, Ltd. in St Leonards. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected September 22, 2011.
Company Profile
This profile covers Advanced Surgical Design & Manufacture, Ltd. based in St Leonards, Australia.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected September 22, 2011.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR - not or inadequately maintained1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 22, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 749929 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Advanced Surgical Design & Manufacture, Ltd.
FEI Number
3003124946
Address
U 2 12 Frederick St, St Leonards, Australia
Country
Australia
ID: 607baad5-66fa-455b-8169-fcd0eb8e3ce0