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Medys S.P.A. FDA Record

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

Latest inspection VAI · Nov 6, 2014
Last warning letter 2013

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest May 14, 2013

510(k) clearances 0 None on file

Medys S.P.A. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Medys S.P.A., the most recent on May 14, 2013.

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

Latest inspection: Nov 6, 2014 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	2	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Medys S.P.A. FDA Warning Letters

1 warning letter on May 14, 2013.

Issued	Subject	Issuing office	Close-out letter
May 14, 2013 · 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

2 inspections from Dec 13, 2012 to Nov 6, 2014.

Date	Site	Product	Classification	FEI
Nov 6, 2014	Garbagnate Milanese, Italy	Devices	Voluntary Action Indicated (VAI)	3000173708
Dec 13, 2012	Garbagnate Milanese, Italy	Devices	Official Action Indicated (OAI)	3000173708

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

Most recent: Warning Letter, May 14, 2013.

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 3000173708	Garbagnate Milanese, Italy	2	Nov 6, 2014

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

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

Yes. FDA has issued 1 warning letter to Medys S.P.A.. The most recent is dated May 14, 2013.

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

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

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

The most recent FDA inspection on file ended Nov 6, 2014 at Garbagnate Milanese, Italy and was classified VAI. FDA has 2 inspections of Medys S.P.A. on file, 1 of them classified OAI (official action indicated).

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