Home / Companies / Mi Gwang Contact Lens Co., Ltd.

Mi Gwang Contact Lens Co., Ltd. FDA Record

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

Latest inspection VAI · Dec 15, 2022
Last warning letter 2012

Inspections 4

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Nov 13, 2012

510(k) clearances 1 Latest Mar 10, 2006

Mi Gwang Contact Lens Co., Ltd. has 0 FDA recalls, 4 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Mi Gwang Contact Lens Co., Ltd., the most recent on Nov 13, 2012.

What these totals cover: FDA records filed under the name "Mi Gwang Contact Lens Co., Ltd." and its spelling variant "Mi Gwang Contact Lens Co".

Latest inspection: Dec 15, 2022 · VAI
Latest 510(k): Mar 10, 2006

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	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Mi Gwang Contact Lens Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Mi Gwang Contact Lens Co., Ltd.: FDA inspections 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	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	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.

Reviewing Mi Gwang Contact Lens Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Mi Gwang Contact Lens Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Mi Gwang Contact Lens Co., Ltd. FDA Warning Letters

1 warning letter on Nov 13, 2012.

Issued	Subject	Issuing office	Close-out letter
Nov 13, 2012 · 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

4 inspections from Jul 5, 2012 to Dec 15, 2022.

Date	Site	Product	Classification	FEI
Dec 15, 2022	Gyeongsan, Korea (The Republic Of)	Devices	Voluntary Action Indicated (VAI)	3003499948
Mar 8, 2018	Gyeongsan, Korea (The Republic Of)	Devices	Voluntary Action Indicated (VAI)	3003499948
Mar 19, 2015	Gyeongsan, Korea (The Republic Of)	Devices	No Action Indicated (NAI)	3003499948
Jul 5, 2012	Gyeongsan, Korea (The Republic Of)	Devices	Official Action Indicated (OAI)	3003499948

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 Mi Gwang Contact Lens Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 13, 2012.

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 3003499948	Gyeongsan, Korea (The Republic Of)	4	Dec 15, 2022

Recent 510(k) clearances

1 510(k) clearance on Mar 10, 2006.

K-Number	Device	Date
K051477	MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED…	Mar 10, 2006

Mi Gwang Contact Lens Co., Ltd. and the FDA: common questions

Has Mi Gwang Contact Lens Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Mi Gwang Contact Lens Co., Ltd.. The most recent is dated Nov 13, 2012.

Has Mi Gwang Contact Lens Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Mi Gwang Contact Lens Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mi Gwang Contact Lens Co., Ltd.?

The most recent FDA inspection on file ended Dec 15, 2022 at Gyeongsan, Korea (The Republic Of) and was classified VAI. FDA has 4 inspections of Mi Gwang Contact Lens Co., Ltd. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Mi Gwang Contact Lens Co., Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.