FDA Inspection 852394 — MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH
The FDA completed an inspection of MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH on Sep 19, 2013 in Tuttlingen. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tuttlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |