Home / Import refusals / AEK-0768117-3/10002/1A

FDA Import Refusal AEK-0768117-3/10002/1A — AbbVie Inc.

AbbVie Inc. — FEI 3009751352

The FDA refused shipment AEK-0768117-3/10002/1A from AbbVie Inc. (United States) on July 10, 2026. The refused product falls under Drugs and Biologics — ONABOTULINUMTOXINA. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 10, 2026
Country
United States
Product Category
Drugs and Biologics
Product Code
58PCZ05 ONABOTULINUMTOXINA
Charges
75

Recent inspections

  • 1299008 (NAI Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1277010 (NAI Thu Aug 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1257605 (NAI Thu Jun 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1231413 (NAI Fri Apr 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1198013 (VAI Tue Jan 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-9968726-6/20003/1 (Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-9161571-9/10001/1 (Sun Dec 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8712399-1/10001/1 (Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7803787-9/10001/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-5627431-4/20002/1 (Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources