Atlas

FDA-Inspected Site

Okami Medical Inc.

2 FDA inspections are on record for Okami Medical Inc. in Aliso Viejo, United States.

483· Form 483 issued

Aliso Viejo, United States · Last updated July 12, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-15.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Dec 2025 – 15 Dec 2025Medical Devices & Rad Health483View 483 →
18 Nov 2024 – 4 Dec 2024Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

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

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

Investigators

FDA investigators tied to this site in the record.

Jordan I Abel1 insp.
Tyler J Chia1 insp.
Alexandria L Capuano1 insp.
Scott D Stevens1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.70(i)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Okami Medical Inc.'s 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat