FDA Intel

Patheon Italia S.p.A. Viale Gian Battista Stucchi 110

Form 483 issued May 26, 2023 · Monza, Italy

Inspection
May 26, 2023
Investigators
Brandy N. Lepage· Mindy M. Chou
Observations
2
Pages
4
FEI number
3003065803

In short: On May 26, 2023, FDA issued a Form 483 with 2 observations to Patheon Italia S.p.A. Viale Gian Battista Stucchi 110 in Monza, Italy (FEI 3003065803) after an inspection that ran May 26, 2023. The investigators were Brandy N. Lepage and Mindy M. Chou. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 2 of 2 observations.

Facilities & equipment1
Production1

Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.113(b) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  2. 02
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Brandy N. Lepage

31 documents · 2021–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.

The firm

Patheon 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 483s

Other sites cited under 211.42(c)(10)(iv)

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 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Patheon Italia S.p.A. Viale Gian Battista Stucchi 110?

Brandy N. Lepage and Mindy M. Chou are named on this Form 483, for the inspection of May 26, 2023. 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?

The inspection ran May 26, 2023, and the Form 483 is dated May 26, 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.

$99Get it free