Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
21 May 2026
ISO 13485:2016 Clause 4.1.5
External party controls do not include written quality agreements
Cited by Dawn M Braswell
21 May 2026
ISO 13485:2016 Clause 7.4.2
Purchasing information lacks written agreement regarding notification of changes
Cited by Dawn M Braswell
21 May 2026
ISO 13485:2016 Clause 7.5.9.1
Procedures for traceability were not documented
Cited by Dawn M Braswell
21 May 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures lack required elements
Cited by Dawn M Braswell
Inspected site
OMOrion Medical Solutions, LLCWatkinsville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.9.1 | 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