Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
15 Dec 2025
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Jordan I Abel, Tyler J Chia
15 Dec 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Jordan I Abel, Tyler J Chia
15 Dec 2025
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Jordan I Abel, Tyler J Chia
Inspected site
OMOkami Medical Inc.Aliso Viejo, United States
Inspection team
TJTyler J Chia
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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