FDA-Inspected Site

GlaxoSmithKline LLC

13 FDA inspections are on record for GlaxoSmithKline LLC in Zebulon, United States.

Clean· No action indicated

Zebulon, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-20.

At a glance

Inspections

13

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Feb 2026 – 20 Feb 2026Human DrugsClean
10 Apr 2024 – 19 Apr 2024Human Drugs483View 483 →
23 Jan 2018 – 26 Jan 2018Human DrugsClean
12 Apr 2016 – 21 Apr 2016Human Drugs483View 483 →
18 Aug 2015 – 21 Aug 2015Human DrugsClean
29 Apr 2013 – 3 May 2013Human DrugsClean
20 Nov 2009Not recordedClean
24 Aug 2009Not recordedClean
1 Aug 2008Not recordedClean
16 Jun 2006Not recordedClean
19 May 2005Not recordedClean
20 May 2003Not recordedClean

Observations on record

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

19 Apr 2024
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Daveta L Bailey, Sonya M Edmonds

21 Apr 2016
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Sonya M Edmonds, Tamara J Henderson, Rebecca Rodriguez

21 Apr 2016
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Sonya M Edmonds, Tamara J Henderson, Rebecca Rodriguez

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind GlaxoSmithKline LLC's 2 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