FDA Inspection 880240 — o.m.t. Oberflachen - und Materialtechnologie Gmbh
The FDA completed an inspection of o.m.t. Oberflachen - und Materialtechnologie Gmbh on April 24, 2014 in Lubeck. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 24, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lubeck (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |