Overview
- 15 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-30.
At a glance
Inspections
15
Form 483s
10
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2026 – 30 Jan 2026 | Biologics | Clean | |
| 10 Feb 2025 – 18 Feb 2025 | Human Drugs | 483 | On file |
| 6 Jun 2022 – 14 Jun 2022 | Human Drugs | Clean | |
| 10 Sep 2018 – 21 Sep 2018 | Human Drugs | 483 | View 483 → |
| 9 Feb 2017 – 17 Feb 2017 | Human Drugs | 483 | View 483 → |
| 26 Oct 2016 – 31 Oct 2016 | Biologics | Clean | |
| 29 Aug 2016 – 7 Sep 2016 | Human Drugs | 483 | On file |
| 7 Dec 2015 – 16 Dec 2015 | Human Drugs | 483 | On file |
| 11 May 2015 – 19 May 2015 | Human Drugs | 483 | View 483 → |
| 28 Oct 2013 – 31 Oct 2013 | Biologics | 483 | On file |
| 13 Jun 2013 – 21 Jun 2013 | Human Drugs | 483 | View 483 → |
| 11 Nov 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Wayne E Seifert2 insp.
Alan L Truong1 insp.
Richard L Bartlett1 insp.
Ekaterina Allen1 insp.
Scott T Ballard1 insp.
Lewis K Antwi1 insp.
Erika V Butler1 insp.
Tiara N Brown-Crosen1 insp.
Aditi Thakur1 insp.
Steven P Donald1 insp.
Simone E Pitts1 insp.
Patric C Klotzbuecher1 insp.
Justin A Boyd1 insp.
Xiaoping Guan1 insp.
Omotunde O Osunsanmi1 insp.
Noreen Muniz1 insp.
Mihaly S Ligmond1 insp.
Xiaokuang Lai1 insp.
Cynthia Jim1 insp.
Caryn M Mcnab1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | 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 | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | 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 Patheon Italia S.p.A's 10 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