Company
United StatesCollaborative Care Diagnostics, LLC dba BioMedix, Eagan, MN – FDA Inspections
Inspection records and compliance data for Collaborative Care Diagnostics, LLC dba BioMedix in Eagan, Minnesota. 5 FDA inspections on record, 1 Form 483, last inspected February 09, 2026.
Company Profile
This profile covers Collaborative Care Diagnostics, LLC dba BioMedix based in Eagan, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected May 5, 2009. Last inspected February 9, 2026.
Most cited issue areas
- Design input - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 9, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1302172 |
| October 18, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1155197 |
| February 10, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 966212 |
| October 28, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 754147 |
| May 5, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 579761 |
FDA documents
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Company Information
Name
Collaborative Care Diagnostics, LLC dba BioMedix
FEI Number
3002619777
Address
860 Blue Gentian Rd Ste 180, Eagan, Minnesota 55121, United States
Country
United States
ID: 70de2368-51b6-488d-a1a4-44deffe74cb3