Dakota Splash, Inc FDA Record

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

Dakota Splash, Inc has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Dakota Splash, Inc" is on file.

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

Latest inspection
May 20, 2026 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Dakota Splash, Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Dakota Splash, Inc: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202400000
202300000
202200000
202100000
202000000
201910000
201800000
201700000

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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Recent FDA inspections

3 inspections from Sep 18, 2012 to May 20, 2026.

DateSiteProductClassificationFEI
May 20, 2026Sioux Falls, SDFood/CosmeticsVoluntary Action Indicated (VAI)2130788
Jun 13, 2019Sioux Falls, SDFood/CosmeticsNo Action Indicated (NAI)2130788
Sep 18, 2012Sioux Falls, SDFood/CosmeticsNo Action Indicated (NAI)2130788
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 2130788Sioux Falls, SD3May 20, 2026

Dakota Splash, Inc and the FDA: common questions

Has Dakota Splash, Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Dakota Splash, Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Dakota Splash, Inc received an FDA Form 483?

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

When did the FDA last inspect Dakota Splash, Inc?

The most recent FDA inspection on file ended May 20, 2026 at Sioux Falls, SD and was classified VAI. FDA has 3 inspections of Dakota Splash, Inc on file.

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