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Soaptronic LLC FDA Record

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

Soaptronic LLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Soaptronic LLC, the most recent on Dec 12, 2019.

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

Latest inspection: Apr 28, 2025 · VAI

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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	6	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

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

Year	Inspections	Warning letters
2026	0	0
2025	1	0
2024	0	0
2023	0	0
2022	0	0
2021	0	0
2020	1	0
2019	0	1
2018	0	0
2017	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.

Soaptronic LLC FDA Warning Letters

1 warning letter on Dec 12, 2019.

Issued	Subject	Issuing office	Close-out letter
Dec 12, 2019

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

6 inspections from Apr 28, 2010 to Apr 28, 2025.

Date	Site	Product	Classification	FEI
Apr 28, 2025	Lake Forest, CA	Drugs	Voluntary Action Indicated (VAI)	2027600
Feb 14, 2020	Lake Forest, CA	Drugs	Voluntary Action Indicated (VAI)	2027600
Jun 23, 2016	Lake Forest, CA	Drugs	Voluntary Action Indicated (VAI)	2027600
Oct 21, 2011	Lake Forest, CA	Drugs	Voluntary Action Indicated (VAI)	2027600
Dec 16, 2010	Lake Forest, CA	Drugs	Voluntary Action Indicated (VAI)	2027600
Apr 28, 2010	Lake Forest, CA	Drugs	Voluntary Action Indicated (VAI)	2027600

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

Most recent: Warning Letter, Dec 12, 2019.

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 2027600	Lake Forest, CA	6	Apr 28, 2025

Soaptronic LLC and the FDA: common questions

Has Soaptronic LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Soaptronic LLC. The most recent is dated Dec 12, 2019.

Has Soaptronic LLC received an FDA Form 483?

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

When did the FDA last inspect Soaptronic LLC?

The most recent FDA inspection on file ended Apr 28, 2025 at Lake Forest, CA and was classified VAI. FDA has 6 inspections of Soaptronic LLC on file.

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