Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3004110157.
Observations6
Issue DateFebruary 18, 2025
StatusNo Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections10
Establishment Details
Firm
Patheon Italia S.p.A
Location
Ferentino, -, Italy
FEI Number
3004110157
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
February 18, 2025
Country
Italy
Inspection History, 2011 to 2026
NAI3
VAI6
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.