Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
6 Apr 2026
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
21 CFR 830.310(b)
GUDID Information required for unique device identification.
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
ISO 13485:2016 Clause 7.3.1
Design and development procedures not documented
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
ISO 13485:2016 Clause 7.3.9
Procedures to control design and development changes not documented
Cited by Matthew M Vernon, Patrick D Galdun
6 Apr 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures lack required elements
Cited by Matthew M Vernon, Patrick D Galdun
Inspected site
CCConMed CorporationGreenwood Village, United States
Inspection team
PDPatrick D Galdun
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 830.310(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.1 | 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 6 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