Home / Import refusals / 94D-1581235-6/21/1

FDA Import Refusal 94D-1581235-6/21/1 — B. Braun US Pharmaceutical Manufacturing, LLC

B. Braun US Pharmaceutical Manufacturing, LLC — FEI 2021236

The FDA refused shipment 94D-1581235-6/21/1 from B. Braun US Pharmaceutical Manufacturing, LLC (United States) on November 15, 2024. The refused product falls under Drugs and Biologics — SODIUM CHLORIDE (REPLENISHER). 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
65RDK19 SODIUM CHLORIDE (REPLENISHER)
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-1581235-6/11/1 (Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-7016121-5/11/1 (Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources