FDA Inspection
Neuromedex GmbHNeuromedex GmbH – FDA Inspection, Sep 26, 2019
Record Details
This FDA Inspection record concerns Neuromedex GmbH, with an inspection on September 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · aa79481e-ec8c-4f0c-93cf-626d74ce04ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102799
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17(b)(2)Reports and information documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Neuromedex GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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