FDA Inspection
Nanovis LLCNanovis LLC – FDA Inspection, Mar 19, 2026
Record Details
This FDA Inspection record concerns Nanovis LLC, with an inspection on March 19, 2026, issued by the Detroit District Office.
- Company
- Nanovis LLC
- Inspection Date
- March 19, 2026
View Company Profile
ID · f1cbd637-3cfb-4ee9-a75e-30b6016d2a46
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1308110
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements
- ISO 13485:2016 Clause 8.5.1Changes to maintain QMS and device not identified and implemented
- ISO 13485:2016 Clause 4.1.4Changes to the QMS not adequately controlled or evaluated
- ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 7.4.2Purchasing information does not include all required elements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nanovis LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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