Atlas

FDA-Inspected Site

Pharmacia Hepar LLC

14 FDA inspections are on record for Pharmacia Hepar LLC in Franklin, United States.

Clean· No action indicated

Franklin, United States · Last updated July 10, 2026

Overview

  • 14 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-05-01.

At a glance

Inspections

14

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Apr 2024 – 1 May 2024Human DrugsClean
20 Feb 2017 – 23 Feb 2017Human DrugsClean
8 Sep 2016 – 20 Sep 2016Human DrugsClean
19 Aug 2014 – 20 Aug 2014Human DrugsClean
11 Jun 2013 – 17 Jun 2013Human DrugsClean
21 Dec 2012Not recordedClean
8 Sep 2011Not recorded483On file
14 Jan 2011Not recordedClean
1 Oct 2010Not recordedClean
18 Aug 2010Not recordedClean
23 Jun 2010Not recordedClean
25 May 2010Not recorded483View 483 →

Observations on record

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

25 May 2010
21 CFR 211.63

Equipment Design, Size and Location

Cited by Michael P Sheehan

25 May 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Michael P Sheehan

25 May 2010
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Michael P Sheehan

Investigators

FDA investigators tied to this site in the record.

Michael P Sheehan4 insp.
Thomas W Nojek4 insp.
Tracey L Harris3 insp.
Kenneth E Felkley2 insp.
Nicholas L Paulin2 insp.
Christopher T Middendorf2 insp.
Lisa R Hilliard1 insp.
Mary B Sheets1 insp.
Cynthia T Cain1 insp.
Anna M Brannen1 insp.
Katie L Korchinski1 insp.
Joshua S Hunt1 insp.
Lindsey M Schwierjohann1 insp.
April E Mcdermitt1 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 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Pharmacia Hepar LLC's 2 Form 483s

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