Company
Denmark3Shape A/S, Copenhagen K, Denmark – FDA Inspections
Inspection records and compliance data for 3Shape A/S in Copenhagen K. 1 FDA inspection on record, last inspected February 09, 2012.
Company Profile
This profile covers 3Shape A/S based in Copenhagen K, Denmark.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected February 9, 2012.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Incorrect translation to production specifications1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 9, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 769413 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
3Shape A/S
FEI Number
3005940400
Address
Holmens Kanal 7, 4 Sal, Copenhagen K, Denmark
Country
Denmark
ID: 2f4caff1-df27-4c33-9d1b-abd4a3c04358