Company
GermanyTEKNO MEDICAL OPTIK-CHIRURGIE GMBH, Tuttlingen, Germany – FDA Inspections
Inspection records and compliance data for TEKNO MEDICAL OPTIK-CHIRURGIE GMBH in Tuttlingen. 4 FDA inspections on record, 1 Form 483, last inspected September 12, 2024.
Company Profile
This profile covers TEKNO MEDICAL OPTIK-CHIRURGIE GMBH based in Tuttlingen, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected July 25, 2013. Last inspected September 12, 2024.
Most cited issue areas
- Quality audits - auditor independence1 inspection
- Quality Audits - defined intervals1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1251709 |
| December 13, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1074283 |
| July 6, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 988493 |
| July 25, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 843002 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH
FEI Number
3002808335
Address
Sattlerstr. 11, Tuttlingen, Germany
Country
Germany
ID: 6268e4a6-3f54-4b12-8e27-c95f75fa478c