Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
9 Feb 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Tyler R Courtney
9 Feb 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Tyler R Courtney
9 Feb 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Tyler R Courtney
Inspected site
CCCollaborative Care Diagnostics, LLC.Eagan, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 801.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 830.300(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
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Form 483 source document
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Full 483 report
Get the verbatim text of all 8 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere