Company
GermanyETI GmbH Ingenieurburo fur Medizintechnik, Karlsruhe, Germany – FDA Inspections
Inspection records and compliance data for ETI GmbH Ingenieurburo fur Medizintechnik in Karlsruhe. 1 FDA inspection on record, 1 Form 483, last inspected April 19, 2018.
Company Profile
This profile covers ETI GmbH Ingenieurburo fur Medizintechnik based in Karlsruhe, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 19, 2018.
Most cited issue areas
- Calibration procedures - content1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 19, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1049540 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ETI GmbH Ingenieurburo fur Medizintechnik
FEI Number
3004133718
Address
Am Sandfeld 4, Karlsruhe, Germany
Country
Germany
ID: ee356fd3-ed7b-4b51-8339-12ac304ca34a