Company
Czech RepublicAlien Technik, Hronov 1, Czech Republic – FDA Inspections
Inspection records and compliance data for Alien Technik in Hronov 1. 2 FDA inspections on record, last inspected February 05, 2016.
Company Profile
This profile covers Alien Technik based in Hronov 1, Czech Republic.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected February 7, 2013. Last inspected February 5, 2016.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Maintenance schedule, Lack of or inadequate schedule1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 5, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 958330 |
| February 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 819441 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Alien Technik
FEI Number
3004133867
Address
Kudrnacova 533, Hronov 1, Czech Republic
Country
Czech Republic
ID: 92838c11-eaf6-4ef8-a504-1e649ad884d3