Atlas

FDA-Inspected Site

Alk-abello A/s

11 FDA inspections are on record for Alk-abello A/s in Horsholm, Denmark.

483· Form 483 issued

Horsholm, Denmark · Last updated July 10, 2026

Overview

  • 11 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-11-25.

At a glance

Inspections

11

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Nov 2019 – 25 Nov 2019Biologics483On file
10 Sep 2018 – 17 Sep 2018Biologics483On file
3 Oct 2016 – 7 Oct 2016BiologicsClean
3 Mar 2016 – 14 Mar 2016BiologicsClean
29 Jan 2014 – 10 Feb 2014Biologics483On file
21 Nov 2011Not recorded483On file
25 Sep 2009Not recorded483On file
10 Nov 2006Not recordedClean
12 Mar 2004Not recordedClean
7 Jun 2002Not recordedClean
10 Mar 2000Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Burnell M Henry2 insp.
Prabhu P Raju2 insp.
Eileen A Liu1 insp.
Joyce A Rockwell1 insp.
Omotunde O Osunsanmi1 insp.
Cynthia Jim1 insp.
Jacqueline M Diaz Albert1 insp.

Full site report

Get the verbatim findings behind Alk-abello A/s' 5 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat