Home / Companies / Firson Co., Ltd.

Firson Co., Ltd. FDA Record

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

Latest inspection OAI · Nov 11, 2016
Last warning letter 2017

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Aug 31, 2017

510(k) clearances 0 None on file

Firson Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Firson Co., Ltd., the most recent on Aug 31, 2017.

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

Latest inspection: Nov 11, 2016 · OAI

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	1	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Reviewing Firson 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 Firson 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

Firson Co., Ltd. FDA Warning Letters

1 warning letter on Aug 31, 2017.

Issued	Subject	Issuing office	Close-out letter
Aug 31, 2017 · 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

1 inspection on Nov 11, 2016.

Date	Site	Product	Classification	FEI
Nov 11, 2016	Cheonan, Korea (The Republic Of)	Drugs	Official Action Indicated (OAI)	3010219111

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

Most recent: Warning Letter, Aug 31, 2017.

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 3010219111	Cheonan, Korea (The Republic Of)	1	Nov 11, 2016

Firson Co., Ltd. and the FDA: common questions

Has Firson Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Firson Co., Ltd.. The most recent is dated Aug 31, 2017.

Has Firson Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Firson Co., Ltd.?

The most recent FDA inspection on file ended Nov 11, 2016 at Cheonan, Korea (The Republic Of) and was classified OAI. FDA has 1 inspection of Firson Co., Ltd. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Firson 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.