Home / Facilities / 3003749112

IPSEN PHARMA BIOTECH FDA Inspection Record

FEI 3003749112 · Inspections, Form 483s, warning letters and import refusals

IPSEN PHARMA BIOTECH is an FDA-registered facility (FEI 3003749112) located in PROVENCE ALPES COTE D'AZUR 83870, FR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 29, 2024: 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
3

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
Mar 29, 2024Voluntary Action Indicated (VAI)No citations listed
Nov 6, 2020Voluntary Action Indicated (VAI)No citations listed
Jun 11, 2018Voluntary Action Indicated (VAI)No citations listed
Jul 12, 2016Voluntary Action Indicated (VAI)Computer control of master formula records (21 CFR 211.68(b))
Air Supply (21 CFR 211.42(c)(10)(iii))
Investigations of discrepancies, failures (21 CFR 211.192)
Jun 24, 2014Voluntary Action Indicated (VAI)Failing drug products not rejected (21 CFR 211.165(f))
Prepared for each batch, include complete information (21 CFR 211.188)
Investigations of discrepancies, failures (21 CFR 211.192)

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

Reviewing IPSEN PHARMA BIOTECH as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check IPSEN PHARMA BIOTECH yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Ipsen Pharma Biotech
Location
PROVENCE ALPES COTE D'AZUR 83870 (FR)
Registration Expires
Dec 31, 2026
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.