Overview
- 17 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-22.
At a glance
Inspections
17
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Apr 2025 – 22 Apr 2025 | Human Drugs | 483 | View 483 → |
| 4 Jan 2023 – 11 Jan 2023 | Human Drugs | 483 | View 483 → |
| 2 Aug 2021 | Human Drugs | Clean | |
| 17 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
| 29 Jan 2018 – 5 Feb 2018 | Human Drugs | Clean | |
| 23 Oct 2017 – 15 Nov 2017 | Human Drugs | Clean | |
| 1 May 2017 – 4 May 2017 | Human Drugs | Clean | |
| 23 Jun 2014 – 27 Jun 2014 | Human Drugs | Clean | |
| 14 Nov 2012 | Not recorded | Clean | |
| 19 Apr 2012 | Not recorded | Clean | |
| 21 Apr 2011 | Not recorded | Clean | |
| 9 Dec 2008 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Dec 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Chiaochun J Wang, Andrew J Barrowcliff, Wayne D Mcgrath
21 Dec 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Chiaochun J Wang, Andrew J Barrowcliff, Wayne D Mcgrath
Investigators
FDA investigators tied to this site in the record.
Kathleen D Culver5 insp.
Michael P Sheehan3 insp.
Logan T Williams2 insp.
Geoffrey K Kilili1 insp.
Wen Ning Chan1 insp.
Chiaochun J Wang1 insp.
Andrew J Barrowcliff1 insp.
Wayne D Mcgrath1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Catalent Pharma Solutions, LLC's 4 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