Home / Import refusals / F23-9340161-7/90002/1

FDA Import Refusal F23-9340161-7/90002/1 — Patheon Italia S.p.A.

Patheon Italia S.p.A. — FEI 3003065803

The FDA refused shipment F23-9340161-7/90002/1 from Patheon Italia S.p.A. (Italy) on September 3, 2025. The refused product falls under Drugs and Biologics — RISANKIZUMAB-RZAA. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 3, 2025
Country
Italy
Product Category
Drugs and Biologics
Product Code
58MCY09 RISANKIZUMAB-RZAA
Charges
75

Recent inspections

  • 1220064 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206297 (VAI Fri May 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1238005 (VAI Thu Jan 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206091 (VAI Fri Apr 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1130741 (VAI Fri Jul 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • F23-9340393-6/20002/2 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9340393-6/20002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BYA-2320462-1/11/1 (Tue Oct 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 334-2798270-8/21/1 (Tue Feb 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 334-2798270-8/11/1 (Tue Feb 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources