FDA Inspection
O.N. Diagnostics, LLCO.N. Diagnostics, LLC – FDA Inspection, Mar 17, 2026
Record Details
This FDA Inspection record concerns O.N. Diagnostics, LLC, with an inspection on March 17, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · 7435cb61-72b4-4d89-839f-ca71824963e8
Inspection Facts
- Inspection number
- 1307862
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
1- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of O.N. Diagnostics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 30, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for O.N. Diagnostics, LLC
- FDA Inspection 1034351 - 2017-11-30
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