Patheon Italia S.p.A
FDA inspection history in Ferentino, Italy, 2016 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Ferentino, Italy.
- 2016The longest 483 on file: 7 observations over 3 pages at Ferentino, Italy.
- 2025One Form 483, at Ferentino, Italy.
Cited most
Across all Patheon Italia S.p.A observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
The complete Patheon Italia S.p.A file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ferentino, Italy
Two Form 483s · 2016 to 2025 · 13 observations
Latest: Form 483, Feb 18, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-18 | 483 Form 483 | Ferentino, Italy | 6 | $99 |
| 2016-09-07 | 483 Form 483 | Ferentino, Italy | 7 | $99 |
Investigators on these documents
FEI number 3004110157 · most recent document Feb 18, 2025
About Patheon Italia S.p.A
How many FDA Form 483s has Patheon Italia S.p.A received?
FDA Intel has 2 Form 483s on file for Patheon Italia S.p.A; the most recent is dated Feb 18, 2025.
When was Patheon Italia S.p.A last inspected by FDA?
The most recent FDA inspection document on file for Patheon Italia S.p.A is a Form 483 dated Feb 18, 2025, for the site in Ferentino, Italy.
What did FDA cite at Patheon Italia S.p.A?
The regulations cited most in the observations on file for Patheon Italia S.p.A are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.