Fareva Pau FDA Inspection Record

FEI 3002806390 ยท Inspections, Form 483s, warning letters and import refusals

Fareva Pau is an FDA-registered facility (FEI 3002806390) located in Idron, FR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 10 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jan 17, 2025: Voluntary Action Indicated (VAI)
Inspections on record
10 (2 OAI, 6 VAI, 2 NAI)
Last OAI inspection
Sep 8, 2009
Warning letters
1 listed by FDA for this FEI, latest Mar 26, 2010
Import refusals
1

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
Jan 17, 2025Voluntary Action Indicated (VAI)No citations listed
Nov 5, 2021Voluntary Action Indicated (VAI)No citations listed
Apr 27, 2018Voluntary Action Indicated (VAI)No citations listed
Apr 13, 2017No Action Indicated (NAI)No citations listed
Jun 10, 2015Voluntary Action Indicated (VAI)Aseptic Processing Area (21 CFR 211.42(c)(10))
Environmental Monitoring System (21 CFR 211.42(c)(10)(iv))
Procedures for sterile drug products (21 CFR 211.113(b))
Feb 26, 2013Voluntary Action Indicated (VAI)Defined areas of adequate size for operations (21 CFR 211.42(c))
Procedures To Be in Writing (21 CFR 211.80(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Equipment construction - reactive surfaces (21 CFR 211.65(a))
and 2 more
May 12, 2011No Action Indicated (NAI)No citations listed
May 12, 2011Voluntary Action Indicated (VAI)No citations listed
Sep 8, 2009Official Action Indicated (OAI)No citations listed
Sep 8, 2009Official Action Indicated (OAI)No citations listed

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
Fareva Pau
Location
Idron (FR)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
decrs

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