Patheon Italia S.p.A. Viale Gian Battista Stucchi 110
Form 483 issued September 5, 2023 · Monza, Italy
- Observations
- 4
- Pages
- 2
- FEI number
- 3003065803
In short: On September 5, 2023, FDA issued a Form 483 with 4 observations to Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 in Monza, Italy (FEI 3003065803). Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.67 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Preventative maintenance on the Sterile Area (SA) fill…
- 02
Adequate procedu res for allocation of equipment and material were not in place prior to the…
- 03
Aseptic process simulations do not fully represent drug product manufacturing…
- 04
The cleaning and disinfecting of the SAQRABS aseptic…
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 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). 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 September 5, 2023.
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.