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FDA Import Refusal SCS-7016121-5/11/1 — B. Braun US Pharmaceutical Manufacturing, LLC

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

The FDA refused shipment SCS-7016121-5/11/1 from B. Braun US Pharmaceutical Manufacturing, LLC (United States) on November 15, 2024. The refused product falls under Drugs and Biologics — CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS. Cited charge: 179 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 15, 2024
Country
United States
Product Category
Drugs and Biologics
Product Code
64ZDK01 CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS
Charges
179

Recent inspections

  • 1292536 (OAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1231010 (NAI Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1226163 (VAI Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1222593 (NAI Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152417 (VAI Tue Aug 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 94D-1581032-7/31/1 (Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 94D-1581032-7/21/1 (Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 94D-1581032-7/11/1 (Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 94D-1581235-6/21/1 (Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 94D-1581235-6/11/1 (Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources