FDA Inspection
HIDREX GmbHHIDREX GmbH – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns HIDREX GmbH, with an inspection on January 26, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a67611a9-bd04-43e9-885a-ed565f3aa4be
Inspection Facts
- Inspection number
- 1002806
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of HIDREX GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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