FDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023
Form 483 issued September 29, 2023
- Inspection
- Sep 21 – Sep 29, 2023
- Investigators
- Alan L. Truong· Scott Ballard
- Observations
- 1
- Pages
- 3
In short: On September 29, 2023, FDA issued a Form 483 with 1 observation to FDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023 after an inspection that ran Sep 21 – Sep 29, 2023. The investigators were Alan L. Truong and Scott Ballard. Most observations concern materials; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.142 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the warehousing of drug…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmFDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.142
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023?
Alan L. Truong and Scott Ballard are named on this Form 483, for the inspection of Sep 21 – Sep 29, 2023. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023 inspected by FDA?
The inspection ran Sep 21 – Sep 29, 2023, and the Form 483 is dated September 29, 2023.
How do I get the full Form 483 for FDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023?
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.