Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
4 Dec 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Alexandria L Capuano, Scott D Stevens
4 Dec 2024
21 CFR 820.184
Lack of or inadequate DHR procedures
Cited by Alexandria L Capuano, Scott D Stevens
4 Dec 2024
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Alexandria L Capuano, Scott D Stevens
4 Dec 2024
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Alexandria L Capuano, Scott D Stevens
4 Dec 2024
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Alexandria L Capuano, Scott D Stevens
Inspected site
OMOkami Medical Inc.Aliso Viejo, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 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 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 7 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