FDA Inspection 1181678 — BERLIN HEART GMBH
The FDA completed an inspection of BERLIN HEART GMBH on Oct 13, 2022 in Berlin. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 13, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |