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.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Oct 2025 – 24 Oct 2025 | Human Drugs | 483 | View 483 → |
| 29 Jan 2024 – 31 Jan 2024 | Human Drugs | Clean | |
| 8 Jul 2019 – 12 Jul 2019 | Human Drugs | 483 | On file |
| 20 Aug 2018 – 24 Aug 2018 | Human Drugs | Clean | |
| 10 Apr 2017 – 13 Apr 2017 | Human Drugs | Clean | |
| 11 Jul 2016 – 14 Jul 2016 | Human Drugs | Clean | |
| 29 Apr 2014 – 2 May 2014 | Human Drugs | Clean | |
| 19 Aug 2013 – 21 Aug 2013 | Human Drugs | Clean | |
| 11 May 2012 | Not recorded | 483 | On file |
| 18 Mar 2011 | Not recorded | 483 | On file |
| 1 Oct 2010 | Not recorded | 483 | On file |
| 13 Nov 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
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.
Seneca D Toms2 insp.
Viviana Matta2 insp.
Hai Lien T Phung2 insp.
Nicole E Knowlton1 insp.
Santos E Camara1 insp.
Jared P Stevens1 insp.
Megan T Ziegler1 insp.
Claire M Minden1 insp.
Lakeesha M Foster1 insp.
William P Tonkins1 insp.
Eric S Clevenger1 insp.
Kara D Dobbin1 insp.
Christopher S Keating1 insp.
Jason F Chancey1 insp.
Tamika D Cathey1 insp.
Thomas R Berry1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
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