Formulated Solutions, LLC FDA Record

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

Formulated Solutions, LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Formulated Solutions, LLC" is on file.

What these totals cover: FDA records filed under the name "Formulated Solutions, LLC" and its spelling variant "Formulated Solutions".

Latest inspection
Apr 4, 2025 · 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
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Formulated Solutions, LLC: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202100000
202000000
201910000
201800000
201710000

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

5 inspections from Feb 11, 2010 to Apr 4, 2025.

DateSiteProductClassificationFEI
Apr 4, 2025Largo, FLDrugsVoluntary Action Indicated (VAI)3005779557
Aug 29, 2019Largo, FLDrugsNo Action Indicated (NAI)3005779557
Dec 8, 2017Largo, FLDevicesVoluntary Action Indicated (VAI)3005779557
Nov 18, 2013Largo, FLDrugsNo Action Indicated (NAI)3005779557
Feb 11, 2010Largo, FLDevicesNo Action Indicated (NAI)3005779557
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 3005779557Largo, FL5Apr 4, 2025

Formulated Solutions, LLC and the FDA: common questions

Has Formulated Solutions, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Formulated Solutions, LLC" 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 Formulated Solutions, LLC received an FDA Form 483?

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

When did the FDA last inspect Formulated Solutions, LLC?

The most recent FDA inspection on file ended Apr 4, 2025 at Largo, FL and was classified VAI. FDA has 5 inspections of Formulated Solutions, LLC on file.

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