FDA Import Refusal FR1-0019184-5/21/1 — NIPRO CORP.

NIPRO CORP. — FEI 3002807710

The FDA refused shipment FR1-0019184-5/21/1 from NIPRO CORP. (Japan) on December 16, 2025. The refused product falls under Devices — DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 16, 2025
Country
Japan
Product Category
Devices
Product Code
78KDI DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Charges
508