FDA-Inspected Site

The Yoshida Dental Manufacturing Co., Ltd.

4 FDA inspections are on record for The Yoshida Dental Manufacturing Co., Ltd. in Sumida, Japan.

Clean· No action indicated

Sumida, Japan · Last updated July 9, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-04.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Dec 2025 – 4 Dec 2025Medical Devices & Rad HealthClean
10 Apr 2023 – 14 Apr 2023Medical Devices & Rad Health483View 483 →
27 Mar 2017 – 31 Mar 2017Medical Devices & Rad Health483View 483 →
2 Sep 2011Not recordedClean

Observations on record

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

14 Apr 2023
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Joshua J Silvestri

14 Apr 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joshua J Silvestri

14 Apr 2023
21 CFR 820.30(c)

Design input - Lack of or inadequate procedures

Cited by Joshua J Silvestri

14 Apr 2023
21 CFR 820.30(d)

Design output - Lack of or inadequate procedures

Cited by Joshua J Silvestri

14 Apr 2023
21 CFR 820.30(g)

Design validation - production units

Cited by Joshua J Silvestri

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 820.100(a)Cited across public-safe Form 483 observations4x
21 CFR 820.30(g)Cited across public-safe Form 483 observations4x
21 CFR 1002.13Cited across public-safe Form 483 observations3x
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 820.198(a)Cited across public-safe Form 483 observations3x
21 CFR 820.30(e)Cited across public-safe Form 483 observations3x
21 CFR 820.30(f)Cited across public-safe Form 483 observations3x
21 CFR 820.90(a)Cited across public-safe Form 483 observations3x
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind The Yoshida Dental Manufacturing Co., Ltd.'s 2 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