Overview
- 18 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-22.
At a glance
Inspections
18
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 May 2026 – 22 May 2026 | Human Drugs | 483 | View 483 → |
| 21 May 2024 – 24 May 2024 | Biologics | 483 | View 483 → |
| 5 Dec 2022 – 15 Dec 2022 | Human Drugs | 483 | View 483 → |
| 21 Sep 2020 – 28 Sep 2020 | Human Drugs | 483 | View 483 → |
| 16 Dec 2019 – 20 Dec 2019 | Human Drugs | Clean | |
| 30 Jul 2019 – 2 Aug 2019 | Human Drugs | Clean | |
| 25 Feb 2019 – 4 Mar 2019 | Human Drugs | 483 | View 483 → |
| 28 Jan 2019 – 1 Feb 2019 | Human Drugs | Clean | |
| 15 May 2017 – 19 May 2017 | Human Drugs | 483 | View 483 → |
| 16 Mar 2015 – 20 Mar 2015 | Human Drugs | 483 | On file |
| 12 Feb 2013 – 14 Feb 2013 | Human Drugs | Clean | |
| 16 Feb 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 May 2026
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Tanya R Syffrard, Harrison E Tandy, Ashley N Samuel
24 May 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Travis S Bradley, Richard L Bartlett
15 Dec 2022
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Adam R Cooke, Philip F Istafanos, Inga M Warr
15 Dec 2022
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Adam R Cooke, Philip F Istafanos, Inga M Warr
Investigators
FDA investigators tied to this site in the record.
Jawaid Hamid3 insp.
Seneca D Toms2 insp.
Michelle D Haamid2 insp.
Tanya R Syffrard1 insp.
Harrison E Tandy1 insp.
Ashley N Samuel1 insp.
Travis S Bradley1 insp.
Richard L Bartlett1 insp.
Adam R Cooke1 insp.
Philip F Istafanos1 insp.
Inga M Warr1 insp.
Gamal A Norton1 insp.
Jared P Stevens1 insp.
Libia M Lugo1 insp.
Sonya M Edmonds1 insp.
Srinivas Chennamaneni1 insp.
Tajah L Blackburn1 insp.
Charanjeet Jassal1 insp.
Barbara M Frazier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Catalent Pharma Solutions LLC's 8 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