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FDA Import Refusal 286-7012499-0/12/4 — Amphastar Nanjing Pharmaceuticals Inc

Amphastar Nanjing Pharmaceuticals Inc — FEI 3009805706

The FDA refused shipment 286-7012499-0/12/4 from Amphastar Nanjing Pharmaceuticals Inc (China) on August 18, 2025. The refused product falls under Drugs and Biologics — HEPARIN SODIUM (ANTI-COAGULANT). Cited charge: 115 This firm has 1 other import refusal on record.

Refusal Details

Date
August 18, 2025
Country
China
Product Category
Drugs and Biologics
Product Code
61LCS08 HEPARIN SODIUM (ANTI-COAGULANT)
Charges
115

Recent inspections

  • 1269036 (NAI Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107981 (VAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036696 (NAI Thu Oct 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969870 (NAI Fri Apr 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874298 (VAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • W33-0774949-7/1/1 (Mon Mar 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources