Patheon Italia S.p.A. Viale Gian Battista Stucchi 110
Form 483 issued November 18, 2022 · Monza, Italy
- Observations
- 8
- Pages
- 5
- FEI number
- 3003065803
In short: On November 18, 2022, FDA issued a Form 483 with 8 observations to Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 in Monza, Italy (FEI 3003065803). Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
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…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Your firm has not established adequate procedural controls to protect the…
- 04
Your firm failed to thoroughly investigate deviations to ensure the investigations identify appropriate root causes and…
This inspection in context
Questions about this 483
What did FDA find at Patheon Italia S.p.A. Viale Gian Battista Stucchi 110?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 inspected by FDA?
This Form 483 is dated November 18, 2022.
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.