Rushing Waters Fisheries, LLC FDA Record

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

Rushing Waters Fisheries, LLC has 3 FDA recalls, 9 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Rushing Waters Fisheries, LLC, the most recent on Nov 17, 2017.

What these totals cover: FDA records filed under the name "Rushing Waters Fisheries, LLC" and its spelling variant "Rushing Waters Fisheries".

Latest recall
F-3487-2017 · Class III · Aug 11, 2017
Latest inspection
Apr 25, 2024 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls3Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Rushing Waters Fisheries, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Rushing Waters Fisheries, LLC: FDA inspections per year 2017: 1 inspections120172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202200000
202110000
202000000
201910000
201811000
201711130

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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Rushing Waters Fisheries, LLC FDA Warning Letters

2 warning letters from Aug 27, 2013 to Nov 17, 2017.

IssuedSubjectIssuing officeClose-out letter
Nov 17, 2017 · Record page
Aug 27, 2013 · 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 recalls

3 recall records on Aug 11, 2017.

NumberClassProductDate
F-3487-2017Class IIIWhole Foods Smoked Whitefish Fillet, packed in bulk boxes. Labeling states: Smoked on: 08/09/17…Aug 11, 2017
F-3486-2017Class IIIWhole Foods Smoked Traditional Atlantic Salmon Portion, packed in bulk boxes. Labeling states…Aug 11, 2017
F-3485-2017Class IIIWhole Foods Smoked Peppered Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked…Aug 11, 2017

Recent FDA inspections

9 inspections from Jun 18, 2009 to Apr 25, 2024.

DateSiteProductClassificationFEI
Apr 25, 2024Palmyra, WIFood/CosmeticsNo Action Indicated (NAI)1000116269
May 18, 2021Palmyra, WIFood/CosmeticsVoluntary Action Indicated (VAI)1000116269
Feb 19, 2019Palmyra, WIFood/CosmeticsVoluntary Action Indicated (VAI)1000116269
May 11, 2018Palmyra, WIFood/CosmeticsOfficial Action Indicated (OAI)1000116269
May 1, 2017Palmyra, WIFood/CosmeticsOfficial Action Indicated (OAI)1000116269
Feb 26, 2014Palmyra, WIFood/CosmeticsVoluntary Action Indicated (VAI)1000116269
May 8, 2013Palmyra, WIFood/CosmeticsOfficial Action Indicated (OAI)1000116269
Jul 27, 2010Palmyra, WIFood/CosmeticsVoluntary Action Indicated (VAI)1000116269
Jun 18, 2009Palmyra, WIFood/CosmeticsNo Action Indicated (NAI)1000116269
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 2 compliance actions under Rushing Waters Fisheries, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 17, 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.

FacilityLocationInspectionsLatest
FEI 1000116269Palmyra, WI9Apr 25, 2024

Rushing Waters Fisheries, LLC and the FDA: common questions

Has Rushing Waters Fisheries, LLC received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Rushing Waters Fisheries, LLC. The most recent is dated Nov 17, 2017.

Has Rushing Waters Fisheries, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Rushing Waters Fisheries, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Rushing Waters Fisheries, LLC?

The most recent FDA inspection on file ended Apr 25, 2024 at Palmyra, WI and was classified NAI. FDA has 9 inspections of Rushing Waters Fisheries, LLC on file, 3 of them classified OAI (official action indicated).

Has Rushing Waters Fisheries, LLC had an FDA recall?

Yes. Rushing Waters Fisheries, LLC has 3 FDA recalls on record. The most recent started Aug 11, 2017.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.