Home / Companies / SMC Ltd.

SMC Ltd.

FDA Regulatory Profile

SMC Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "SMC Ltd." and its spelling variant "Smc".

Latest inspection: Dec 11, 2025 · VAI

Reviewing SMC 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 SMC 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

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

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	6	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA Record by Year

SMC Ltd.'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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	3	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.

Recent FDA Inspections

6 inspections from Dec 18, 2013 to Dec 11, 2025.

Date	Site	Product	Classification	FEI
Dec 11, 2025	Gimpo, Korea (The Republic Of)	Devices	Voluntary Action Indicated (VAI)	3011221234
Jun 4, 2019	Devens, MA	Devices	No Action Indicated (NAI)	3012349753
Mar 12, 2019	Devens, MA	Drugs	No Action Indicated (NAI)	3012349753
Mar 6, 2019	Twinsburg, OH	Devices	No Action Indicated (NAI)	3013536540
Jun 14, 2018	Nicholasville, KY	Devices	No Action Indicated (NAI)	3009627223
Dec 18, 2013	Devens, MA	Devices	No Action Indicated (NAI)	3012349753

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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

4 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3011221234	Gimpo, Korea (The Republic Of)	1	Dec 11, 2025
FEI 3012349753	Devens, MA	3	Jun 4, 2019
FEI 3013536540	Twinsburg, OH	1	Mar 6, 2019
FEI 3009627223	Nicholasville, KY	1	Jun 14, 2018

Need more than this page shows? Ask about SMC 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.