Patheon Italia S.p.A. Viale Gian Battista Stucchi 110
FDA inspection history in Monza, Italy, 2021 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2022: one Form 483; 2023: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Four Form 483s, at Monza, Italy.
- 2022The longest 483 on file: 8 observations over 5 pages at Monza, Italy.
Cited most
Across all Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
The complete Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 file.
All 4 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
Monza, Italy
Four Form 483s · 2021 to 2023 · 14 observations
Latest: Form 483, Sep 5, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-05 | 483 Form 483 | Monza, Italy | 4 | $99 |
| 2023-05-26 | 483 Form 483 | Monza, Italy | 2 | $99 |
| 2022-11-18 | 483 Form 483 | Monza, Italy | 8 | $99 |
| 2021-09-03 | 483 Form 483 | Monza, Italy | — | $99 |
Investigators on these documents
FEI number 3003065803 · most recent document Sep 5, 2023
About Patheon Italia S.p.A. Viale Gian Battista Stucchi 110
How many FDA Form 483s has Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 received?
FDA Intel has 4 Form 483s on file for Patheon Italia S.p.A. Viale Gian Battista Stucchi 110; the most recent is dated Sep 5, 2023.
When was Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 last inspected by FDA?
The most recent FDA inspection document on file for Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 is a Form 483 dated Sep 5, 2023, for the site in Monza, Italy.
What did FDA cite at Patheon Italia S.p.A. Viale Gian Battista Stucchi 110?
The regulations cited most in the observations on file for Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.