Atlas

FDA-Inspected Site

Orion Corporation, Orion Pharma

11 FDA inspections are on record for Orion Corporation, Orion Pharma in Espoo, Finland.

483· Form 483 issued

Espoo, Finland · Last updated July 10, 2026

Overview

  • 11 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-06-01.

At a glance

Inspections

11

Form 483s

7

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 May 2018 – 1 Jun 2018Human Drugs483View 483 →
19 Apr 2017 – 21 Apr 2017Human Drugs483On file
5 Sep 2016 – 13 Sep 2016Animal Drugs & Feeds483On file
28 Aug 2014 – 5 Sep 2014Human Drugs483View 483 →
20 Dec 2012Not recorded483View 483 →
2 Nov 2012Not recorded483On file
14 Sep 2010Not recorded483View 483 →
25 Oct 2007Not recordedClean
11 Feb 2003Not recordedClean
13 Dec 2002Not recordedClean
28 Jun 2001Not recordedClean

Observations on record

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

1 Jun 2018
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jogy George, Rodney G Raiford

1 Jun 2018
21 CFR 211.188(b)(5)

In-Process and Laboratory Control Results

Cited by Jogy George, Rodney G Raiford

1 Jun 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Jogy George, Rodney G Raiford

1 Jun 2018
21 CFR 211.25(a)

GMP Training Frequency

Cited by Jogy George, Rodney G Raiford

1 Jun 2018
21 CFR 211.42(c)(10)

Aseptic Processing Area

Cited by Jogy George, Rodney G Raiford

Investigators

FDA investigators tied to this site in the record.

Jogy George1 insp.
Rodney G Raiford1 insp.
Joshua P Wireman1 insp.
Kellia N Hicks1 insp.
Margaret M Annes1 insp.
Cheryl L Love Harris1 insp.
Brooke K Higgins1 insp.
Liatte Krueger1 insp.
Ileana Barreto-Pettit1 insp.
Sarah E Mcmullen1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.25(a)Cited across public-safe Form 483 observations4x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.101(d)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.89Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Orion Corporation, Orion Pharma's 7 Form 483s

Source PDFs, verbatim observations, 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