Overview
- 18 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-10.
At a glance
Inspections
18
Form 483s
11
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 10 Feb 2026 | Biologics | 483 | View 483 → |
| 21 Sep 2023 – 29 Sep 2023 | Biologics | 483 | On file |
| 28 Aug 2023 – 5 Sep 2023 | Human Drugs | 483 | On file |
| 18 May 2023 – 26 May 2023 | Human Drugs | 483 | On file |
| 4 Apr 2023 – 8 Apr 2023 | Human Drugs | Clean | |
| 10 Nov 2022 – 18 Nov 2022 | Human Drugs | 483 | On file |
| 30 Aug 2021 – 3 Sep 2021 | Human Drugs | 483 | On file |
| 24 Oct 2018 – 2 Nov 2018 | Human Drugs | Clean | |
| 29 Jan 2018 – 6 Feb 2018 | Human Drugs | Clean | |
| 12 May 2016 – 20 May 2016 | Human Drugs | 483 | On file |
| 27 May 2015 – 4 Jun 2015 | Human Drugs | 483 | On file |
| 31 Mar 2014 – 8 Apr 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2023
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Scott T Ballard, Alan L Truong
26 May 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Mindy M Chou, Brandy N Lepage
26 May 2023
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Mindy M Chou, Brandy N Lepage
26 May 2023
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Mindy M Chou, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Lewis K Antwi1 insp.
Peng Zhou1 insp.
Scott T Ballard1 insp.
Alan L Truong1 insp.
Richard Ledwidge1 insp.
Mindy M Chou1 insp.
Brandy N Lepage1 insp.
MRA M BarbosaR1 insp.
Zhong Li1 insp.
Melissa D Ray1 insp.
Michael Shanks1 insp.
Viviana Matta1 insp.
Jessica L Pressley1 insp.
Steven P Donald1 insp.
Ivis L Negron Torres1 insp.
Laura Fontan1 insp.
Zhihao Pete Qiu1 insp.
Jose A Cruz Gonzalez1 insp.
Noreen Muniz1 insp.
Joseph R Lambert1 insp.
Omotunde O Osunsanmi1 insp.
Mihaly S Ligmond1 insp.
Caryn M Mcnab1 insp.
Susan F Laska1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Patheon Italia S.p.A.'s 11 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