FDA Inspection
neuroConn GmbHneuroConn GmbH – FDA Inspection, Jan 12, 2023
Record Details
This FDA Inspection record concerns neuroConn GmbH, with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3e8c884-dcbb-4a1a-85e9-dfd9b6a1b476
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195429
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.120(b)Labeling inspection - UDI
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120(b)Labeling inspection - UDI
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of neuroConn GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2025 | NAI | Compliance: Devices | |
| November 9, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for neuroConn GmbH
- FDA Inspection 1298214 - 2025-12-09
- FDA Inspection 1031057 - 2017-11-09
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