Atlas

FDA-Inspected Site

Akorn Inc.

20 FDA inspections are on record for Akorn Inc. in Somerset, United States.

483· Form 483 issued

Somerset, United States · Last updated July 9, 2026

Overview

  • 20 FDA inspections are on record.
  • 10 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-05-17.

At a glance

Inspections

20

Form 483s

10

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Apr 2022 – 17 May 2022Human Drugs483View 483 →
23 Jul 2018 – 30 Aug 2018Human Drugs483View 483 →
2 May 2017 – 12 May 2017Human DrugsClean
22 Feb 2016 – 4 Apr 2016Human Drugs483On file
19 May 2015 – 5 Jun 2015Human Drugs483On file
7 Apr 2014 – 29 May 2014Human Drugs483On file
1 Feb 2013Not recorded483On file
11 May 2012Not recorded483On file
19 May 2011Not recorded483View 483 →
6 Oct 2009Not recordedClean
12 Jun 2009Not recordedClean
10 Oct 2008Not recordedClean

Observations on record

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

17 May 2022
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Guerlain Ulysse, Mindy M Chou, Ko U Min, Nicholas A Violand, Natasha Gupta

17 May 2022
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Guerlain Ulysse, Mindy M Chou, Ko U Min, Nicholas A Violand, Natasha Gupta

17 May 2022
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Guerlain Ulysse, Mindy M Chou, Ko U Min, Nicholas A Violand, Natasha Gupta

17 May 2022
21 CFR 211.166(a)

Written program not followed

Cited by Guerlain Ulysse, Mindy M Chou, Ko U Min, Nicholas A Violand, Natasha Gupta

17 May 2022
21 CFR 211.186(a)

Written procedures followed

Cited by Guerlain Ulysse, Mindy M Chou, Ko U Min, Nicholas A Violand, Natasha Gupta

Investigators

FDA investigators tied to this site in the record.

Paul L Bellamy3 insp.
Barbara J Wilimczyk-Macri3 insp.
Guerlain Ulysse2 insp.
Ko U Min2 insp.
Tamil Arasu2 insp.
Russell J Glapion2 insp.
Mindy M Chou1 insp.
Nicholas A Violand1 insp.
Natasha Gupta1 insp.
Atul Agrawal1 insp.
Adetutu M Gidado1 insp.
Nancy M Espinal1 insp.
Unnee Ranjan1 insp.
Jose M Cayuela1 insp.
Liatte Krueger1 insp.
Michael R Klapal1 insp.
Paula J Bretz1 insp.
Joseph F Mcginnis1 insp.
Daniel J Grabicki1 insp.
Annemarie Bodnar1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations10x
21 CFR 211.22(a)Cited across public-safe Form 483 observations6x
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations3x
21 CFR 211.166(a)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.68(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Akorn Inc.'s 10 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