Luen Fook Medicine Sdn. Bhd. FDA Record

Summary

FDA record by year

Luen Fook Medicine Sdn. Bhd.'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.

Luen Fook Medicine Sdn. Bhd. FDA Warning Letters

1 warning letter on Apr 8, 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

2 inspections from May 22, 2015 to Dec 14, 2018.

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 Luen Fook Medicine Sdn. Bhd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 8, 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.

Luen Fook Medicine Sdn. Bhd. and the FDA: common questions

Has Luen Fook Medicine Sdn. Bhd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Luen Fook Medicine Sdn. Bhd.. The most recent is dated Apr 8, 2019.

Has Luen Fook Medicine Sdn. Bhd. received an FDA Form 483?

FDA has not published a Form 483 for "Luen Fook Medicine Sdn. Bhd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Luen Fook Medicine Sdn. Bhd.?

The most recent FDA inspection on file ended Dec 14, 2018 at Johor Bahru, Malaysia and was classified OAI. FDA has 2 inspections of Luen Fook Medicine Sdn. Bhd. on file, 1 of them classified OAI (official action indicated).