LEO Pharma A/S — FDA Facility Profile

FEI 3002807496

LEO Pharma A/S is an FDA-registered facility (FEI 3002807496) located in Region Hovedstaden, DK. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

Reviewing LEO Pharma A/S 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 LEO Pharma A/S 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

What FDA found at this site

Latest inspection
Sep 26, 2024: Voluntary Action Indicated (VAI)
Inspections on record
6 (1 OAI, 5 VAI)
Last OAI inspection
Jun 16, 2009
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
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
Sep 26, 2024Voluntary Action Indicated (VAI)No citations listed
Jun 17, 2021Voluntary Action Indicated (VAI)No citations listed
Mar 21, 2014Voluntary Action Indicated (VAI)No citations listed
Sep 15, 2011Voluntary Action Indicated (VAI)No citations listed
Jul 15, 2011Voluntary Action Indicated (VAI)No citations listed
Jun 16, 2009Official Action Indicated (OAI)No citations listed

Facility details

Company
Leo Pharma A/S
Location
Region Hovedstaden (DK)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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