FDA-Inspected Site

Catalent Greenville Inc

14 FDA inspections are on record for Catalent Greenville Inc in Greenville, United States.

483· Form 483 issued

Greenville, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-10-24.

At a glance

Inspections

14

Form 483s

5

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Oct 2025 – 24 Oct 2025Human Drugs483View 483 →
29 Jan 2024 – 31 Jan 2024Human DrugsClean
8 Jul 2019 – 12 Jul 2019Human Drugs483View 483 →
20 Aug 2018 – 24 Aug 2018Human DrugsClean
10 Apr 2017 – 13 Apr 2017Human DrugsClean
11 Jul 2016 – 14 Jul 2016Human DrugsClean
29 Apr 2014 – 2 May 2014Human DrugsClean
19 Aug 2013 – 21 Aug 2013Human DrugsClean
11 May 2012Not recorded483View 483 →
18 Mar 2011Not recorded483View 483 →
1 Oct 2010Not recorded483View 483 →
13 Nov 2009Not recordedClean

Observations on record

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

24 Oct 2025
21 CFR 211.165(b)

Microbiological testing

Cited by Nicole E Knowlton, Santos E Camara

24 Oct 2025
21 CFR 211.166(a)

Written program not followed

Cited by Nicole E Knowlton, Santos E Camara

24 Oct 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicole E Knowlton, Santos E Camara

12 Jul 2019
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Claire M Minden, Lakeesha M Foster

12 Jul 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Claire M Minden, Lakeesha M Foster

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 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(f)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited 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 Catalent Greenville Inc's 5 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