System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh FDA Record

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

  • Latest inspection OAI · Feb 18, 2022
  • Last warning letter 2022
Inspections 1 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Sep 9, 2022
510(k) clearances 0 None on file

System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh, the most recent on Sep 9, 2022.

What these totals cover: FDA records filed under the name "System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh" and its spelling variant "System Kosmetik Produktionsgesellschaft Fur Kosmetische".

Latest inspection
Feb 18, 2022 · OAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh FDA Warning Letters

1 warning letter on Sep 9, 2022.

IssuedSubjectIssuing officeClose-out letter
Sep 9, 2022 · Letter on fda.gov CGMP/Finished Pharmaceuticals/AdulteratedCenter for Drug Evaluation and Research | CDER

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

1 inspection on Feb 18, 2022.

DateSiteProductClassificationFEI
Feb 18, 2022Munster, GermanyDrugsOfficial Action Indicated (OAI)3011408975
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 System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 20, 2022.

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.

FacilityLocationInspectionsLatest
FEI 3011408975Munster, Germany1Feb 18, 2022

System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh and the FDA: common questions

Has System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh received an FDA warning letter?

Yes. FDA has issued 1 warning letter to System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh. The most recent is dated Sep 9, 2022, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".

Has System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh received an FDA Form 483?

FDA has not published a Form 483 for "System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh?

The most recent FDA inspection on file ended Feb 18, 2022 at Munster, Germany and was classified OAI. FDA has 1 inspection of System Kosmetik Produktionsgesellschaft Fur Kosmetische Gmbh on file, 1 of them classified OAI (official action indicated).

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.