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Artsana S.P.A FDA Record

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

Latest inspection NAI · Jul 20, 2017
Last warning letter 2011

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jun 3, 2011

510(k) clearances 3 Latest Feb 10, 2016

Artsana S.P.A has 0 FDA recalls, 3 inspections, 3 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Artsana S.P.A, the most recent on Jun 3, 2011.

What these totals cover: FDA records filed under the name "Artsana S.P.A" and its spelling variant "Artsana".

Latest inspection: Jul 20, 2017 · NAI
Latest 510(k): Feb 10, 2016

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	3	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Artsana S.P.A FDA Warning Letters

1 warning letter on Jun 3, 2011.

Issued	Subject	Issuing office	Close-out letter
Jun 3, 2011 · 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

3 inspections from Jan 27, 2011 to Jul 20, 2017.

Date	Site	Product	Classification	FEI
Jul 20, 2017	Casnate Con Bernate, Italy	Devices	No Action Indicated (NAI)	3002807528
May 9, 2013	Casnate Con Bernate, Italy	Devices	No Action Indicated (NAI)	3002807528
Jan 27, 2011	Casnate Con Bernate, Italy	Devices	Official Action Indicated (OAI)	3002807528

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 Artsana S.P.A: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 3, 2011.

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 3002807528	Casnate Con Bernate, Italy	3	Jul 20, 2017

Recent 510(k) clearances

3 510(k) clearances from Oct 4, 2005 to Feb 10, 2016.

K-Number	Device	Date
K151311	Safe Block Pen Needle	Feb 10, 2016
K052667	ARTSANA PISTON AND INSULIN SYRINGES	Nov 25, 2005
K051783	ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES	Oct 4, 2005

Artsana S.P.A and the FDA: common questions

Has Artsana S.P.A received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Artsana S.P.A. The most recent is dated Jun 3, 2011.

Has Artsana S.P.A received an FDA Form 483?

FDA has not published a Form 483 for "Artsana S.P.A" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Artsana S.P.A?

The most recent FDA inspection on file ended Jul 20, 2017 at Casnate Con Bernate, Italy and was classified NAI. FDA has 3 inspections of Artsana S.P.A on file, 1 of them classified OAI (official action indicated).

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