FDA Inspection 913845 — PAR Medizintechnik GmbH & Co. KG
The FDA completed an inspection of PAR Medizintechnik GmbH & Co. KG on Jan 21, 2015 in Berlin. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 21, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |