Home / Import refusals / AEK-8218999-2/11/1

FDA Import Refusal AEK-8218999-2/11/1 — Abbott Laboratories

Abbott Laboratories — FEI 1415939

The FDA refused shipment AEK-8218999-2/11/1 from Abbott Laboratories (United States) on March 4, 2025. The refused product falls under Drugs and Biologics — ADALIMUMAB. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 4, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
58SDY14 ADALIMUMAB
Charges
75

Recent inspections

  • 1229076 (NAI Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084371 (VAI Fri Mar 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024377 (NAI Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012920 (VAI Thu Feb 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936765 (VAI Tue Aug 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-7975909-6/10001/1 (Fri Dec 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7475392-0/20001/1 (Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9F2-7239382-6/10002/1 (Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8225554-6/11/1 (Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8202077-5/11/1 (Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources