Atlas

FDA-Inspected Site

Aomori Olympus Co., Ltd.

3 FDA inspections are on record for Aomori Olympus Co., Ltd. in Kuroishi, Japan.

483· Form 483 issued

Kuroishi, Japan · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-07.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Nov 2025 – 7 Nov 2025Medical Devices & Rad Health483View 483 →
11 Jul 2022 – 14 Jul 2022Medical Devices & Rad Health483View 483 →
29 Feb 2016 – 2 Mar 2016Medical Devices & Rad HealthClean

Observations on record

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

7 Nov 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey

7 Nov 2025
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey

7 Nov 2025
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Stephen D Eich, Janet Pulver, Rebecca E Dorsey

14 Jul 2022
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Thai T Duong

14 Jul 2022
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Thai T Duong

Investigators

FDA investigators tied to this site in the record.

Stephen D Eich1 insp.
Janet Pulver1 insp.
Rebecca E Dorsey1 insp.
Thai T Duong1 insp.
Cynthia A Harris1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations5x
21 CFR 820.75(a)Cited across public-safe Form 483 observations5x
21 CFR 803.17Cited across public-safe Form 483 observations4x
21 CFR 803.52(c)(3)Cited across public-safe Form 483 observations4x
21 CFR 820.184Cited across public-safe Form 483 observations4x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Aomori Olympus Co., Ltd.'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