FDA-Inspected Site

ZIOSOFT, INC.

1 FDA inspection is on record for ZIOSOFT, INC. in Minato, Japan.

483· Form 483 issued

Minato, Japan · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-12-18.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Dec 2025 – 18 Dec 2025Medical Devices & Rad Health483View 483 →

Observations on record

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

18 Dec 2025
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Sunita Pandey

18 Dec 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Sunita Pandey

18 Dec 2025
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Sunita Pandey

18 Dec 2025
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Sunita Pandey

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 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ZIOSOFT, INC.'s 1 Form 483

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