Atlas

FDA-Inspected Site

Nikkiso Ltd - Shizuoka Plant

3 FDA inspections are on record for Nikkiso Ltd - Shizuoka Plant in Makinohara, Japan.

483· Form 483 issued

Makinohara, Japan · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-21.

At a glance

Inspections

3

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 May 2026 – 21 May 2026Medical Devices & Rad Health483On file
22 Feb 2016Medical Devices & Rad HealthClean
4 Mar 2013 – 7 Mar 2013Medical Devices & Rad Health483On file

Investigators

FDA investigators tied to this site in the record.

Stephen D Eich1 insp.
Leonard H Lavi1 insp.
Kelvin Cheung1 insp.

Full site report

Get the verbatim findings behind Nikkiso Ltd - Shizuoka Plant's 2 Form 483s

The full inspection record, as Atlas holds it, 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