FDA Inspection
Clarus Medical, LlcClarus Medical, Llc – FDA Inspection, May 22, 2025
Record Details
This FDA Inspection record concerns Clarus Medical, Llc, with an inspection on May 22, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 592c9ed8-24cf-4ada-829b-627698a2c0f3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1270474
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Clarus Medical, Llc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 23, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Clarus Medical, Llc
- FDA Inspection 1137113 - 2021-03-10
- FDA Inspection 1063426 - 2018-08-23
- FDA Inspection 922562 - 2015-04-13
- FDA Inspection 735517 - 2011-07-25
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