FDA Inspection 820220 — Loewenstein Medical Technology GMBH + CO. KG
The FDA completed an inspection of Loewenstein Medical Technology GMBH + CO. KG on Jan 31, 2013 in Hamburg. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hamburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |