FDA-Inspected Site

Fuji Dynamics Limited

3 FDA inspections are on record for Fuji Dynamics Limited in Dong Guan, China.

Clean· No action indicated

Dong Guan, China · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-04-23.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Apr 2026 – 23 Apr 2026Medical Devices & Rad HealthClean
21 Oct 2019 – 24 Oct 2019Medical Devices & Rad HealthClean
6 Mar 2017 – 9 Mar 2017Medical Devices & Rad Health483View 483 →

Observations on record

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

9 Mar 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by That Q Dang

9 Mar 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by That Q Dang

9 Mar 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by That Q Dang

9 Mar 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by That Q Dang

9 Mar 2017
21 CFR 820.100(b)

Documentation

Cited by That Q Dang

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 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(b)Cited across public-safe Form 483 observations2x
21 CFR 820.25(b)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Fuji Dynamics Limited's 1 Form 483

Verbatim observations 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