FDA Inspection
neuroConn GmbHneuroConn GmbH – FDA Inspection, Nov 9, 2017
Record Details
This FDA Inspection record concerns neuroConn GmbH, with an inspection on November 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · aead4a75-96af-431b-88f5-2336d7b20642
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031057
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of neuroConn GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2025 | NAI | Compliance: Devices | |
| January 12, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for neuroConn GmbH
- FDA Inspection 1298214 - 2025-12-09
- FDA Inspection 1195429 - 2023-01-12
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