FDA Inspection
Biosensics LLCBiosensics LLC – FDA Inspection, Feb 9, 2026
Record Details
This FDA Inspection record concerns Biosensics LLC, with an inspection on February 9, 2026, issued by the New England District Office, covering medical devices & rad health.
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ID · 7ddccce2-1614-43fa-a53c-99fda2dc25ab
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1301914
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
3- ISO 13485:2016 Clause 8.5.2Corrective action not taken
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
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Other FDA inspections of Biosensics LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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