FDA Inspection 864721 — Moeller Medical GmbH
The FDA completed an inspection of Moeller Medical GmbH on Jan 30, 2014 in Fulda. 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fulda (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2481 | 21 CFR 820.30(c) | Design input procedures - addressing conflicting requirement |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3691 | 21 CFR 820.100(a)(4) | Verification vs validation |
| 4071 | 21 CFR 820.30(i) | Design changes - validation vs. verification |