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

FEI 3001109714 · Inspections, Form 483s, warning letters and import refusals

Inaudi Clemente & C. S.R.L. is an FDA-inspected facility (FEI 3001109714) located in Borgo San Dalmazzo, IT. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Dec 14, 2018: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Apr 28, 2010
Warning letters
1 listed by FDA for this FEI, latest Aug 13, 2010
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Dec 14, 2018Voluntary Action Indicated (VAI)Visual indicators not used (21 CFR 113.87(b))
Electronic records (21 CFR 113.100(h))
TID accuracy test frequency (21 CFR 113.40(a)(1))
Coding - required elements (21 CFR 113.60(c))
and 1 more
Jul 12, 2011No Action Indicated (NAI)No citations listed
Apr 28, 2010Official Action Indicated (OAI)Scheduled processes not established (21 CFR 113.83)
Scheduled process - scientific methods not used (21 CFR 113.83)
Manufacturing conditions (21 CFR 110.80(b)(2))
No accurate TID (21 CFR 113.40(b)(1))
and 3 more

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIDec 14, 20186 x 0.251.5
Warning letter on FDA's dashboard, which does not show close-outsAug 13, 201010 years or older, so it adds no points0
Inspection classified OAIApr 28, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Inaudi Clemente & C. S.R.L.
Location
Borgo San Dalmazzo (IT)
Source
inspections

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.