FDA Inspection 872444 — CM Instrumente GmbH
The FDA completed an inspection of CM Instrumente GmbH on Apr 3, 2014 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 3, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tuttlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |