FDA Inspection 1308110 — Nanovis LLC
The FDA completed an inspection of Nanovis LLC on March 19, 2026 in Columbia City, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 19, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Columbia City, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23023 | ISO 13485:2016 Clause 4.1.4 | Changes to the QMS not adequately controlled or evaluated |
| 23080 | ISO 13485:2016 Clause 6.4.1 | Work environment requirements and procedures not documented |
| 23146 | ISO 13485:2016 Clause 7.4.2 | Purchasing information does not include all required elements |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23170 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes lack required elements |
| 23254 | ISO 13485:2016 Clause 8.5.1 | Changes to maintain QMS and device not identified and implemented |