FDA-Inspected Site

Sakura Seiki Co., Ltd. Chikuma Factory

3 FDA inspections are on record for Sakura Seiki Co., Ltd. Chikuma Factory in Chikuma, Japan.

483· Form 483 issued

Chikuma, Japan · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-05.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Mar 2026 – 5 Mar 2026Medical Devices & Rad Health483On file
20 Mar 2023 – 24 Mar 2023Medical Devices & Rad Health483View 483 →
12 Feb 2019 – 15 Feb 2019Medical Devices & Rad Health483On file

Observations on record

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

24 Mar 2023
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Melanie W Pishnery

24 Mar 2023
21 CFR 803.56

Submission of Supplement to Individual Report Within One Month

Cited by Melanie W Pishnery

24 Mar 2023
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Melanie W Pishnery

24 Mar 2023
21 CFR 820.20(c)

Management review - defined interval, sufficient frequency

Cited by Melanie W Pishnery

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 803.56Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sakura Seiki Co., Ltd. Chikuma Factory's 3 Form 483s

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