FDA Inspection
Collaborative Care Diagnostics, LLC dba BioMedixCollaborative Care Diagnostics, LLC dba BioMedix – FDA Inspection, Oct 18, 2021
Record Details
This FDA Inspection record concerns Collaborative Care Diagnostics, LLC dba BioMedix, with an inspection on October 18, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 18, 2021
- Product Type
- Devices
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ID · a1bdfbec-a722-4acd-b876-5dd8ae43d6da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155197
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Collaborative Care Diagnostics, LLC dba BioMedix
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2026 | NAI | Minneapolis District Office | Postmarket Assurance: Medical Devices |
| February 10, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 28, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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