FDA Inspection
HIDREX GmbHHIDREX GmbH – FDA Inspection, Nov 9, 2023
Record Details
This FDA Inspection record concerns HIDREX GmbH, with an inspection on November 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 70cfdecc-fa00-4bb0-b38e-5e273f72cda8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1222347
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(c)Investigation of device failures
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Other FDA inspections of HIDREX GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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