Atlas

FDA-Inspected Site

HOYA Corporation PENTAX Miyagi Factory

4 FDA inspections are on record for HOYA Corporation PENTAX Miyagi Factory in Kurihara, Japan.

483· Form 483 issued

Kurihara, Japan · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-08-03.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
31 Jul 2023 – 3 Aug 2023Medical Devices & Rad Health483View 483 →
22 Apr 2015 – 24 Apr 2015Medical Devices & Rad Health483View 483 →
18 Nov 2013 – 21 Nov 2013Medical Devices & Rad Health483View 483 →
16 Dec 2010Not recorded483On file

Observations on record

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

3 Aug 2023
21 CFR 820.40(b)

Change records, content

Cited by Kwong P Lee

24 Apr 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Nicole S Williams, Linda Linh T Nguyen

24 Apr 2015
21 CFR 820.184

DHR content

Cited by Nicole S Williams, Linda Linh T Nguyen

24 Apr 2015
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Nicole S Williams, Linda Linh T Nguyen

21 Nov 2013
21 CFR 820.40

Lack of procedures, or not maintained

Cited by Amy M Cramer

Investigators

FDA investigators tied to this site in the record.

Kwong P Lee1 insp.
Nicole S Williams1 insp.
Linda Linh T Nguyen1 insp.
Amy M Cramer1 insp.
Michael J Nerz1 insp.

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 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.40(b)Cited across public-safe Form 483 observations1x
21 CFR 820.70(e)Cited 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 HOYA Corporation PENTAX Miyagi Factory's 4 Form 483s

Source PDFs, 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