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Chiesi Farmaceutici S.P.A. FDA Inspection Record

FEI 3002806655 · Inspections, Form 483s, warning letters and import refusals

Chiesi Farmaceutici S.P.A. is an FDA-registered facility (FEI 3002806655) located in Parma, IT. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Sep 29, 2023: Voluntary Action Indicated (VAI)
Inspections on record
5 (5 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
5

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
Sep 29, 2023Voluntary Action Indicated (VAI)No citations listed
Nov 23, 2018Voluntary Action Indicated (VAI)No citations listed
Jul 26, 2018Voluntary Action Indicated (VAI)No citations listed
Jul 29, 2016Voluntary Action Indicated (VAI)Habits of good sanitation & health (21 CFR 211.28(b))
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
Sanitation--buildings not clean, free of infestation (21 CFR 211.56(a))
Control procedures to monitor and validate performance (21 CFR 211.110(a))
and 2 more
Jul 8, 2011Voluntary Action Indicated (VAI)General responsibilities of sponsors (21 CFR 312.50)

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 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 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Chiesi Farmaceutici S.P.A.
Location
Parma (IT)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

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