Overview
- 15 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-30.
At a glance
Inspections
15
Form 483s
9
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jan 2026 – 30 Jan 2026 | Human Drugs | 483 | On file |
| 28 May 2024 – 30 May 2024 | Human Drugs | Clean | |
| 23 Jan 2024 – 25 Jan 2024 | Medical Devices & Rad Health | Clean | |
| 17 Jul 2023 – 21 Jul 2023 | Foods & Cosmetics | 483 | View 483 → |
| 26 Aug 2019 – 28 Aug 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2019 – 22 Feb 2019 | Human Drugs | 483 | View 483 → |
| 29 May 2018 – 14 Jun 2018 | Human Drugs | 483 | View 483 → |
| 14 Mar 2016 – 25 Mar 2016 | Human Drugs | 483 | View 483 → |
| 9 Dec 2013 – 30 Dec 2013 | Human Drugs | 483 | View 483 → |
| 21 Jun 2012 | Not recorded | Clean | |
| 29 Mar 2011 | Not recorded | 483 | View 483 → |
| 6 Mar 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jul 2023
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Jose Perez-Soto, Lourdes Andujar, Moraima J Ramos-Valle
21 Jul 2023
21 CFR 111.255(b)
Batch record - complete
Cited by Jose Perez-Soto, Lourdes Andujar, Moraima J Ramos-Valle
21 Jul 2023
21 CFR 111.27(d)
Equipment - maintain, clean, sanitize
Cited by Jose Perez-Soto, Lourdes Andujar, Moraima J Ramos-Valle
21 Jul 2023
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Jose Perez-Soto, Lourdes Andujar, Moraima J Ramos-Valle
21 Jul 2023
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Jose Perez-Soto, Lourdes Andujar, Moraima J Ramos-Valle
Investigators
FDA investigators tied to this site in the record.
Nicole E Knowlton2 insp.
Ileana Barreto-Pettit2 insp.
Damaris Y Hernandez1 insp.
Tammy T Brown1 insp.
Kayla V Sprague1 insp.
Monica C Burgos Garcia1 insp.
Jose Perez-Soto1 insp.
Lourdes Andujar1 insp.
Moraima J Ramos-Valle1 insp.
Joshua J Silvestri1 insp.
Jessica L Pressley1 insp.
Jennifer Lalama1 insp.
Christos G Tsingelis1 insp.
Saleem A Akhtar1 insp.
Jogy George1 insp.
Michael H Tollon1 insp.
Jennifer A Robinson1 insp.
Kimberly M Hull1 insp.
Salvatore N Randazzo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Catalent Pharma Solutions, LLC's 9 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