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Hoya Corporation - Pentax Life Division FDA Record

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

Latest inspection OAI · Apr 21, 2015
Last warning letter 2023

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 2 Latest Jan 1, 2023

510(k) clearances 0 None on file

Hoya Corporation - Pentax Life Division has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Hoya Corporation - Pentax Life Division, the most recent on Jan 1, 2023.

What these totals cover: FDA records filed under the name "Hoya Corporation - Pentax Life Division".

Latest inspection: Apr 21, 2015 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Hoya Corporation - Pentax Life Division's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Hoya Corporation - Pentax Life Division: FDA recall records per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	1	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	1	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Hoya Corporation - Pentax Life Division FDA Warning Letters

2 warning letters from Mar 9, 2018 to Jan 1, 2023.

Issued	Subject	Issuing office	Close-out letter
Jan 1, 2023 · Record page
Mar 9, 2018 · 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

2 inspections from Jul 15, 2014 to Apr 21, 2015.

Date	Site	Product	Classification	FEI
Apr 21, 2015	Akishima, Japan	Devices	Official Action Indicated (OAI)	3008185830
Jul 15, 2014	Akishima, Japan	Devices	No Action Indicated (NAI)	3008185830

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 2 compliance actions under Hoya Corporation - Pentax Life Division: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 1, 2023.

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 3008185830	Akishima, Japan	2	Apr 21, 2015

Hoya Corporation - Pentax Life Division and the FDA: common questions

Has Hoya Corporation - Pentax Life Division received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Hoya Corporation - Pentax Life Division. The most recent is dated Jan 1, 2023.

Has Hoya Corporation - Pentax Life Division received an FDA Form 483?

FDA has not published a Form 483 for "Hoya Corporation - Pentax Life Division" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hoya Corporation - Pentax Life Division?

The most recent FDA inspection on file ended Apr 21, 2015 at Akishima, Japan and was classified OAI. FDA has 2 inspections of Hoya Corporation - Pentax Life Division on file, 1 of them classified OAI (official action indicated).

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