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Lodato Gennaro & C S.P.A. FDA Record

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

Latest inspection OAI · Nov 27, 2014
Last warning letter 2013

Inspections 3

3 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Mar 7, 2013

510(k) clearances 0 None on file

Lodato Gennaro & C S.P.A. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Lodato Gennaro & C S.P.A., the most recent on Mar 7, 2013.

What these totals cover: FDA records filed under the name "Lodato Gennaro & C S.P.A." and its spelling variant "Lodato Gennaro And C".

Latest inspection: Nov 27, 2014 · OAI

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	3	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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Lodato Gennaro & C S.P.A. FDA Warning Letters

1 warning letter on Mar 7, 2013.

Issued	Subject	Issuing office	Close-out letter
Mar 7, 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

3 inspections from Jul 6, 2010 to Nov 27, 2014.

Date	Site	Product	Classification	FEI
Nov 27, 2014	Castel San Giorgio, Italy	Food/Cosmetics	Official Action Indicated (OAI)	3004670115
Nov 20, 2012	Castel San Giorgio, Italy	Food/Cosmetics	Official Action Indicated (OAI)	3004670115
Jul 6, 2010	Castel San Giorgio, Italy	Food/Cosmetics	Official Action Indicated (OAI)	3004670115

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

Most recent: Warning Letter, Mar 7, 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 3004670115	Castel San Giorgio, Italy	3	Nov 27, 2014

Lodato Gennaro & C S.P.A. and the FDA: common questions

Has Lodato Gennaro & C S.P.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Lodato Gennaro & C S.P.A.. The most recent is dated Mar 7, 2013.

Has Lodato Gennaro & C S.P.A. received an FDA Form 483?

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

When did the FDA last inspect Lodato Gennaro & C S.P.A.?

The most recent FDA inspection on file ended Nov 27, 2014 at Castel San Giorgio, Italy and was classified OAI. FDA has 3 inspections of Lodato Gennaro & C S.P.A. on file, 3 of them classified OAI (official action indicated).

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