Home / Companies / FSS, Inc.

FSS, Inc. FDA Record

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

FSS, Inc. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to FSS, Inc., the most recent on Jun 18, 2015.

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

Latest inspection: Apr 8, 2025 · 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	7	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

FSS, 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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	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 FSS, Inc. 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 FSS, Inc. 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

FSS, Inc. FDA Warning Letters

1 warning letter on Jun 18, 2015.

Issued	Subject	Issuing office	Close-out letter
Jun 18, 2015

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

7 inspections from May 11, 2012 to Apr 8, 2025.

Date	Site	Product	Classification	FEI
Apr 8, 2025	Red Wing, MN	Food/Cosmetics	No Action Indicated (NAI)	3002706429
Oct 20, 2021	Red Wing, MN	Food/Cosmetics	Voluntary Action Indicated (VAI)	3002706429
Dec 11, 2018	Red Wing, MN	Food/Cosmetics	No Action Indicated (NAI)	3002706429
Dec 9, 2015	Red Wing, MN	Food/Cosmetics	Voluntary Action Indicated (VAI)	3002706429
Jan 9, 2015	Red Wing, MN	Food/Cosmetics	Official Action Indicated (OAI)	3002706429
Apr 9, 2013	Red Wing, MN	Food/Cosmetics	Voluntary Action Indicated (VAI)	3002706429
May 11, 2012	Red Wing, MN	Food/Cosmetics	Voluntary Action Indicated (VAI)	3002706429

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 FSS, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 18, 2015.

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 3002706429	Red Wing, MN	7	Apr 8, 2025

FSS, Inc. and the FDA: common questions

Has FSS, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to FSS, Inc.. The most recent is dated Jun 18, 2015.

Has FSS, Inc. received an FDA Form 483?

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

When did the FDA last inspect FSS, Inc.?

The most recent FDA inspection on file ended Apr 8, 2025 at Red Wing, MN and was classified NAI. FDA has 7 inspections of FSS, Inc. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about FSS, Inc. 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.