Smak Sp. Z O.O. FDA Record

Summary

Smak Sp. Z O.O. FDA Warning Letters

1 warning letter on May 15, 2012.

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 Jan 27, 2012 to Aug 13, 2014.

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 Smak Sp. Z O.O.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 15, 2012.

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.

Smak Sp. Z O.O. and the FDA: common questions

Has Smak Sp. Z O.O. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Smak Sp. Z O.O.. The most recent is dated May 15, 2012.

Has Smak Sp. Z O.O. received an FDA Form 483?

FDA has not published a Form 483 for "Smak Sp. Z O.O." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Smak Sp. Z O.O.?

The most recent FDA inspection on file ended Aug 13, 2014 at Zory, Poland and was classified NAI. FDA has 2 inspections of Smak Sp. Z O.O. on file, 1 of them classified OAI (official action indicated).