FDA Inspection 1049540 — ETI GmbH Ingenieurburo Fur Medizintechnik
The FDA completed an inspection of ETI GmbH Ingenieurburo Fur Medizintechnik on Apr 19, 2018 in Karlsruhe. 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). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Karlsruhe (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3328 | 21 CFR 820.180(b) | Retention period |