Patheon Italia S.p.A
Form 483 issued February 18, 2025 · Ferentino, Italy
- Inspection
- Feb 10 – Feb 18, 2025
- Investigators
- Ekaterina Allen· Wayne Seifert
- Observations
- 6
- Pages
- 10
- FEI number
- 3004110157
In short: On February 18, 2025, FDA issued a Form 483 with 6 observations to Patheon Italia S.p.A in Ferentino, Italy (FEI 3004110157) after an inspection that ran Feb 10 – Feb 18, 2025. The investigators were Ekaterina Allen and Wayne Seifert. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 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
Quality Unit (QU) oversight over the…
- 02
Failure to establish process controls and testing designed to assure that the drug products you manufacture…
- 03
Procedures designed to prevent microbiological contamination of drug product purporting to be sterile are not…
- 04
Your program for the visual inspection of sterile drug products does not provide adequate assurance that…
This inspection in context
Ekaterina Allen
6 documents · 2021–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Italy.
The firmPatheon Italia S.p.A history
All 2 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?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. 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?
Ekaterina Allen and Wayne Seifert are named on this Form 483, for the inspection of Feb 10 – Feb 18, 2025. Each investigator has a profile showing what they cite most.
When was Patheon Italia S.p.A inspected by FDA?
The inspection ran Feb 10 – Feb 18, 2025, and the Form 483 is dated February 18, 2025.
How do I get the full Form 483 for Patheon Italia S.p.A?
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.