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Nobilus Ent Oddzial Kutno FDA Record

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

Nobilus Ent Oddzial Kutno has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Nobilus Ent Oddzial Kutno, the most recent on Mar 7, 2012.

What these totals cover: FDA records filed under the name "Nobilus Ent Oddzial Kutno".

Latest inspection: May 9, 2024 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Nobilus Ent Oddzial Kutno's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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.

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Nobilus Ent Oddzial Kutno FDA Warning Letters

1 warning letter on Mar 7, 2012.

Issued	Subject	Issuing office	Close-out letter
Mar 7, 2012 · Record page

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

5 inspections from Sep 15, 2011 to May 9, 2024.

Date	Site	Product	Classification	FEI
May 9, 2024	Kutno, Poland	Drugs	Voluntary Action Indicated (VAI)	3008517755
Jul 11, 2019	Kutno, Poland	Drugs	Voluntary Action Indicated (VAI)	3008517755
Sep 15, 2017	Kutno, Poland	Drugs	No Action Indicated (NAI)	3008517755
Dec 18, 2014	Kutno, Poland	Drugs	No Action Indicated (NAI)	3008517755
Sep 15, 2011	Kutno, Poland	Drugs	Official Action Indicated (OAI)	3008517755

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 Nobilus Ent Oddzial Kutno: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 7, 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.

Facility	Location	Inspections	Latest
FEI 3008517755	Kutno, Poland	5	May 9, 2024

Nobilus Ent Oddzial Kutno and the FDA: common questions

Has Nobilus Ent Oddzial Kutno received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Nobilus Ent Oddzial Kutno. The most recent is dated Mar 7, 2012.

Has Nobilus Ent Oddzial Kutno received an FDA Form 483?

FDA has not published a Form 483 for "Nobilus Ent Oddzial Kutno" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Nobilus Ent Oddzial Kutno?

The most recent FDA inspection on file ended May 9, 2024 at Kutno, Poland and was classified VAI. FDA has 5 inspections of Nobilus Ent Oddzial Kutno on file, 1 of them classified OAI (official action indicated).

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