Sunshine USA, LLC FDA Record

Summary

FDA record by year

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

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.

Sunshine USA, LLC FDA Warning Letters

2 warning letters from Nov 20, 2012 to Dec 5, 2013.

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 Jan 15, 2010 to Apr 28, 2025.

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

Most recent: Warning Letter, Dec 5, 2013.

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.

Sunshine USA, LLC and the FDA: common questions

Has Sunshine USA, LLC received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Sunshine USA, LLC. The most recent is dated Dec 5, 2013.

Has Sunshine USA, LLC received an FDA Form 483?

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

When did the FDA last inspect Sunshine USA, LLC?

The most recent FDA inspection on file ended Apr 28, 2025 at Johnson City, TN and was classified VAI. FDA has 7 inspections of Sunshine USA, LLC on file, 2 of them classified OAI (official action indicated).