Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-20.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 20 Jan 2026 | Biologics | Clean | |
| 9 Jul 2024 – 16 Jul 2024 | Human Drugs | 483 | On file |
| 19 Jun 2024 – 25 Jun 2024 | Biologics | Clean | |
| 2 Aug 2023 – 8 Aug 2023 | Biologics | Clean | |
| 12 Nov 2015 – 20 Nov 2015 | Human Drugs | 483 | View 483 → |
| 24 Jun 2013 – 2 Jul 2013 | Human Drugs | 483 | View 483 → |
| 8 Mar 2012 | Not recorded | 483 | On file |
| 15 Mar 2011 | Not recorded | 483 | View 483 → |
| 27 Jun 2008 | Not recorded | 483 | On file |
| 20 Oct 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2015
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christophe T Peters, Chad N Thompson
20 Nov 2015
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christophe T Peters, Chad N Thompson
20 Nov 2015
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Christophe T Peters, Chad N Thompson
20 Nov 2015
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Christophe T Peters, Chad N Thompson
20 Nov 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Christophe T Peters, Chad N Thompson
Investigators
FDA investigators tied to this site in the record.
Carla A Norris2 insp.
Alan L Truong1 insp.
Richard L Bartlett1 insp.
Thuy T Nguyen1 insp.
Ruo H Xu1 insp.
Ekaterina Allen1 insp.
Prajakta A Varadkar1 insp.
Sharmila Shrestha1 insp.
Anthony F Lorenzo1 insp.
Erin C Hill1 insp.
Viviana R Ramirez1 insp.
Christophe T Peters1 insp.
Chad N Thompson1 insp.
Marie F Morin1 insp.
Temar Q Williams1 insp.
Denise M Digiulio1 insp.
Stephen D Brown1 insp.
Demitria J Xiradakis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(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 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Catalent Anagni SRL's 6 Form 483s
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