Far East Summit LLC FDA Record

Summary

FDA record by year

Far East Summit 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.

Far East Summit LLC FDA Warning Letters

1 warning letter on Sep 13, 2024.

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 Jul 27, 2016 to Apr 18, 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 1 compliance action under Far East Summit LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 13, 2024.

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.

Far East Summit LLC and the FDA: common questions

Has Far East Summit LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Far East Summit LLC. The most recent is dated Sep 13, 2024, with the subject "Unapproved New Drugs/Misbranded".

Has Far East Summit LLC received an FDA Form 483?

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

When did the FDA last inspect Far East Summit LLC?

The most recent FDA inspection on file ended Apr 18, 2025 at Dexter, OR and was classified VAI. FDA has 6 inspections of Far East Summit LLC on file, 1 of them classified OAI (official action indicated).