FDA Inspection 1336816 — Viscus Biologics LLC
The FDA completed an inspection of Viscus Biologics LLC on Sep 22, 2026 in Warrensville Heights, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 22, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Warrensville Heights, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23170 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes lack required elements |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |