Inaudi Clemente & C. S.R.L. FDA Record

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

  • Latest inspection VAI · Dec 14, 2018
  • Last warning letter 2010
Inspections 3 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Aug 13, 2010
510(k) clearances 0 None on file

Inaudi Clemente & C. S.R.L. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Inaudi Clemente & C. S.R.L., the most recent on Aug 13, 2010.

What these totals cover: FDA records filed under the name "Inaudi Clemente & C. S.R.L." and its spelling variant "Inaudi Clemente And C".

Latest inspection
Dec 14, 2018 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections3Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Inaudi Clemente & C. S.R.L. FDA Warning Letters

1 warning letter on Aug 13, 2010.

IssuedSubjectIssuing officeClose-out letter
Aug 13, 2010 · 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 Apr 28, 2010 to Dec 14, 2018.

DateSiteProductClassificationFEI
Dec 14, 2018Borgo San Dalmazzo, ItalyFood/CosmeticsVoluntary Action Indicated (VAI)3001109714
Jul 12, 2011Borgo San Dalmazzo, ItalyFood/CosmeticsNo Action Indicated (NAI)3001109714
Apr 28, 2010Borgo San Dalmazzo, ItalyFood/CosmeticsOfficial Action Indicated (OAI)3001109714
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 Inaudi Clemente & C. S.R.L.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 13, 2010.

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 3001109714Borgo San Dalmazzo, Italy3Dec 14, 2018

Inaudi Clemente & C. S.R.L. and the FDA: common questions

Has Inaudi Clemente & C. S.R.L. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Inaudi Clemente & C. S.R.L.. The most recent is dated Aug 13, 2010.

Has Inaudi Clemente & C. S.R.L. received an FDA Form 483?

FDA has not published a Form 483 for "Inaudi Clemente & C. S.R.L." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Inaudi Clemente & C. S.R.L.?

The most recent FDA inspection on file ended Dec 14, 2018 at Borgo San Dalmazzo, Italy and was classified VAI. FDA has 3 inspections of Inaudi Clemente & C. S.R.L. 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.