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Menicon America, Inc. FDA Record

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

Menicon America, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Menicon America, Inc." is on file.

What these totals cover: FDA records filed under the name "Menicon America, Inc." and its spelling variant "Menicon America".

Latest inspection: Dec 19, 2024 · NAI

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	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Menicon America, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

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

3 inspections from Aug 26, 2015 to Dec 19, 2024.

Date	Site	Product	Classification	FEI
Dec 19, 2024	North Billerica, MA	Devices	No Action Indicated (NAI)	3003515967
Jan 9, 2020	North Billerica, MA	Devices	No Action Indicated (NAI)	3003515967
Aug 26, 2015	North Billerica, MA	Devices	Voluntary Action Indicated (VAI)	3003515967

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.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003515967	North Billerica, MA	3	Dec 19, 2024

Menicon America, Inc. and the FDA: common questions

Has Menicon America, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Menicon America, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Menicon America, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Menicon America, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Menicon America, Inc.?

The most recent FDA inspection on file ended Dec 19, 2024 at North Billerica, MA and was classified NAI. FDA has 3 inspections of Menicon America, Inc. on file.

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