Patheon Italia S.p.A. Viale Gian Battista Stucchi 110
Form 483 issued September 3, 2021 · Monza, Italy
- Investigator
- Michael R. Shanks
- Observations
- 1
- Pages
- 1
- FEI number
- 3003065803
In short: On September 3, 2021, FDA issued a Form 483 with 1 observation to Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 in Monza, MB (FEI 3003065803). The investigator was Michael R. Shanks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmPatheon Italia S.p.A. Viale Gian Battista Stucchi 110 history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Italia S.p.A. Viale Gian Battista Stucchi 110?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Patheon Italia S.p.A. Viale Gian Battista Stucchi 110?
Michael R. Shanks is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 inspected by FDA?
This Form 483 is dated September 3, 2021.
How do I get the full Form 483 for Patheon Italia S.p.A. Viale Gian Battista Stucchi 110?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.