Atlas

FDA-Inspected Site

Octapharma AB

13 FDA inspections are on record for Octapharma AB in Stockholm, Sweden.

483· Form 483 issued

Stockholm, Sweden · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 11 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-09-19.

At a glance

Inspections

13

Form 483s

11

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Sep 2023 – 19 Sep 2023Biologics483View 483 →
19 Sep 2018 – 28 Sep 2018Biologics483On file
16 Sep 2016 – 3 Oct 2016Biologics483On file
7 Jul 2016 – 14 Jul 2016Biologics483On file
21 Oct 2014 – 28 Oct 2014Biologics483On file
14 Apr 2014 – 28 Apr 2014Biologics483On file
7 Oct 2013 – 11 Oct 2013Biologics483On file
30 Jul 2012Not recorded483On file
19 Jan 2012Not recorded483On file
20 Jan 2011Not recordedWLOn file
29 Jan 2009Not recorded483On file
20 Nov 2006Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

19 Sep 2023
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Scott T Ballard, Ze Peng, Alan L Truong, Olga Simakova

19 Sep 2023
21 CFR 211.110(a)

Written in-process control procedures

Cited by Scott T Ballard, Ze Peng, Alan L Truong, Olga Simakova

19 Sep 2023
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Scott T Ballard, Ze Peng, Alan L Truong, Olga Simakova

Investigators

FDA investigators tied to this site in the record.

Cynthia Jim2 insp.
Anthony F Lorenzo2 insp.
Jie He2 insp.
Michael J Vardon2 insp.
Susan M Jackson2 insp.
Mihaly S Ligmond2 insp.
Scott T Ballard1 insp.
Ze Peng1 insp.
Alan L Truong1 insp.
Olga Simakova1 insp.
Eileen A Liu1 insp.
Prabhu P Raju1 insp.
Jennifer L Reed1 insp.
Debra M Emerson1 insp.
Pankaj H Amin1 insp.
Randa Melhem1 insp.
Jacqueline M Diaz Albert1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Octapharma AB's 11 Form 483s

Source PDFs and recurring CFR citations, 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