FDA Inspection
TEKNO MEDICAL OPTIK-CHIRURGIE GMBHTEKNO MEDICAL OPTIK-CHIRURGIE GMBH – FDA Inspection, Dec 13, 2018
Record Details
This FDA Inspection record concerns TEKNO MEDICAL OPTIK-CHIRURGIE GMBH, with an inspection on December 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 18091e2e-8e01-4f8e-90f6-15da05b1e5da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074283
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.22Quality Audits - defined intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TEKNO MEDICAL OPTIK-CHIRURGIE GMBH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 6, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for TEKNO MEDICAL OPTIK-CHIRURGIE GMBH
- FDA Inspection 1251709 - 2024-09-12
- FDA Inspection 988493 - 2016-07-06
- FDA Inspection 843002 - 2013-07-25
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