FDA Inspection
Nuwellis IncNuwellis Inc – FDA Inspection, Aug 17, 2026
Record Details
This FDA Inspection record concerns Nuwellis Inc, with an inspection on August 17, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 196e78b7-9bce-4067-ab1d-2118a3ec0125
Inspection Facts
- Inspection number
- 1331480
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
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Other FDA inspections of Nuwellis Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 6, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nuwellis Inc
- FDA Inspection 1203388 - 2023-04-13
- FDA Inspection 1005020 - 2016-12-06
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