Home / Import refusals / B8P-1505724-7/11/1

FDA Import Refusal B8P-1505724-7/11/1 — Amgen Technology (Ireland) Unlimited Company

Amgen Technology (Ireland) Unlimited Company — FEI 3002808497

The FDA refused shipment B8P-1505724-7/11/1 from Amgen Technology (Ireland) Unlimited Company (Ireland) on July 13, 2023. The refused product falls under Drugs and Biologics — TRASTUZUMAB (ANTI-NEOPLASTIC - PART II). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 13, 2023
Country
Ireland
Product Category
Drugs and Biologics
Product Code
62ZCZ35 TRASTUZUMAB (ANTI-NEOPLASTIC - PART II)
Charges
27

Recent inspections

  • 1241641 (NAI Thu Jul 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1221006 (NAI Wed Sep 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1228800 (VAI Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114773 (VAI Fri Oct 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067928 (NAI Thu Sep 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-9518811-8/12/1 (Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • B8P-1506332-8/21/1 (Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 101-5818412-7/11/1 (Thu Mar 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 101-5818521-5/11/1 (Thu Mar 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 101-5818554-6/11/1 (Thu Mar 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources