Company
Poland3Shape Poland, Szczecin, Poland – FDA Inspections
Inspection records and compliance data for 3Shape Poland in Szczecin. 2 FDA inspections on record, 1 Form 483, last inspected June 30, 2017.
Company Profile
This profile covers 3Shape Poland based in Szczecin, Poland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 26, 2013. Last inspected June 30, 2017.
Most cited issue areas
- DHR content1 inspection
- Lack of or inadequate process validation1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 30, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1016400 |
| September 26, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 851801 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
3Shape Poland
FEI Number
3015172511
Address
Ul. Poludniowa 27c, Szczecin, Poland
Country
Poland
ID: 9fa04a3a-2a78-4b83-8ab3-64833cfa8744