Atlas

FDA-Inspected Site

AGC Biologics A/S

4 FDA inspections are on record for AGC Biologics A/S in Soborg, Denmark.

483· Form 483 issued

Soborg, Denmark · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-05-10.

At a glance

Inspections

4

Form 483s

2

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 May 2021 – 10 May 2021Human Drugs483On file
28 Oct 2019 – 5 Nov 2019Human Drugs483On file
30 Oct 2017 – 7 Nov 2017BiologicsClean
7 Oct 2015 – 13 Oct 2015BiologicsClean

Investigators

FDA investigators tied to this site in the record.

Michael Shanks1 insp.
Reyes Candau-Chacon1 insp.
Simone E Pitts1 insp.
Donald B Ertel1 insp.

Full site report

Get the verbatim findings behind AGC Biologics A/S' 2 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