FDA Inspection
Viscus Biologics LLCViscus Biologics LLC – FDA Inspection, May 9, 2024
Record Details
This FDA Inspection record concerns Viscus Biologics LLC, with an inspection on May 9, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eefea5a9-6585-4326-9a8f-026bca130117
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1238083
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Viscus Biologics LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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