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HOYA Corporation PENTAX Miyagi Factory FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Apr 24, 2015
Last warning letter 2015

Inspections 3

0 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Aug 12, 2015

510(k) clearances 0 None on file

HOYA Corporation PENTAX Miyagi Factory has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to HOYA Corporation PENTAX Miyagi Factory, the most recent on Aug 12, 2015.

What these totals cover: FDA records filed under the name "HOYA Corporation PENTAX Miyagi Factory".

Latest inspection: Apr 24, 2015 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	3	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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HOYA Corporation PENTAX Miyagi Factory FDA Warning Letters

1 warning letter on Aug 12, 2015.

Issued	Subject	Issuing office	Close-out letter
Aug 12, 2015 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Dec 16, 2010 to Apr 24, 2015.

Date	Site	Product	Classification	FEI
Apr 24, 2015	Kurihara, Japan	Devices	Voluntary Action Indicated (VAI)	3003782610
Nov 21, 2013	Kurihara, Japan	Devices	Voluntary Action Indicated (VAI)	3003782610
Dec 16, 2010	Kurihara, Japan	Devices	Voluntary Action Indicated (VAI)	3003782610

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under HOYA Corporation PENTAX Miyagi Factory: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 12, 2015.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003782610	Kurihara, Japan	3	Apr 24, 2015

HOYA Corporation PENTAX Miyagi Factory and the FDA: common questions

Has HOYA Corporation PENTAX Miyagi Factory received an FDA warning letter?

Yes. FDA has issued 1 warning letter to HOYA Corporation PENTAX Miyagi Factory. The most recent is dated Aug 12, 2015.

Has HOYA Corporation PENTAX Miyagi Factory received an FDA Form 483?

FDA has not published a Form 483 for "HOYA Corporation PENTAX Miyagi Factory" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect HOYA Corporation PENTAX Miyagi Factory?

The most recent FDA inspection on file ended Apr 24, 2015 at Kurihara, Japan and was classified VAI. FDA has 3 inspections of HOYA Corporation PENTAX Miyagi Factory on file.

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