Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
22 May 2026
ISO 13485:2016 Clause 4.1.5
Inadequate monitoring and control over outsourced processes
Cited by Nikki S Bryant, Karen M Cruz Arenas
22 May 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Nikki S Bryant, Karen M Cruz Arenas
22 May 2026
ISO 13485:2016 Clause 7.3.3
Design and development inputs incomplete or inadequate
Cited by Nikki S Bryant, Karen M Cruz Arenas
22 May 2026
ISO 13485:2016 Clause 7.3.6
Inadequate design and development verification for interfaced device
Cited by Nikki S Bryant, Karen M Cruz Arenas
Inspected site
CMContego Medical, IncRaleigh, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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