FDA Inspection 1074283 — TEKNO MEDICAL OPTIK-CHIRURGIE GMBH
The FDA completed an inspection of TEKNO MEDICAL OPTIK-CHIRURGIE GMBH on Dec 13, 2018 in Tuttlingen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tuttlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |