FDA Inspection
Viscus Biologics LLCViscus Biologics LLC – FDA Inspection, Sep 22, 2026
Record Details
This FDA Inspection record concerns Viscus Biologics LLC, with an inspection on September 22, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Viscus Biologics LLC
- Inspection Date
- September 22, 2026
- Product Type
- Devices
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ID · 6a9128dc-3e4d-4f26-bb72-b65f0ca0ec13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336816
- Project area
- Compliance: Devices
FDA Citations
3- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements
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Other FDA inspections of Viscus Biologics LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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