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FDA Import Refusal AEK-9429853-3/71/1 — Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC — FEI 3002733956

The FDA refused shipment AEK-9429853-3/71/1 from Fresenius Kabi USA, LLC (United States) on July 22, 2021. The refused product falls under Drugs and Biologics — OXYTOCIN (INJECTION) (OXYTOCIC). Cited charges: 118,3280,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 22, 2021
Country
United States
Product Category
Drugs and Biologics
Product Code
65DCK06 OXYTOCIN (INJECTION) (OXYTOCIC)
Charges
118,3280,75

Recent inspections

  • 1231341 (NAI Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113433 (NAI Mon Nov 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019250 (NAI Fri Apr 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897983 (NAI Mon Oct 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 783661 (VAI Fri May 04 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 9SN-0007009-6/91/1 (Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9SN-0007009-6/141/1 (Mon Feb 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8JB-0093850-4/11/10 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8JB-0093850-4/11/31 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8JB-0093850-4/11/65 (Wed Mar 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources