FDA Inspection 1222347 — HIDREX GmbH
The FDA completed an inspection of HIDREX GmbH on Nov 9, 2023 in Heiligenhaus. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 9, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Heiligenhaus (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |