Company
Denmark3SHAPE TRIOS A/S, Copenhagen K, Denmark – FDA Inspections
Inspection records and compliance data for 3SHAPE TRIOS A/S in Copenhagen K. 1 FDA inspection on record, 1 Form 483, last inspected June 30, 2017.
Company Profile
This profile covers 3SHAPE TRIOS A/S based in Copenhagen K, Denmark.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected June 30, 2017.
Most cited issue areas
- Design plans- updated1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design validation - production units1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 30, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1016399 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
3SHAPE TRIOS A/S
FEI Number
3009560013
Address
Holmens Kanal 7, Copenhagen K, Denmark
Country
Denmark
ID: 4bf0908c-df43-469d-9cf9-8f0687b54dd3