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FDA Import Refusal NUV-3849643-9/10002/1 — Unither Manufacturing LLC.

Unither Manufacturing LLC. — FEI 1314625

The FDA refused shipment NUV-3849643-9/10002/1 from Unither Manufacturing LLC. (United States) on November 4, 2025. The refused product falls under Drugs and Biologics — CERTOLIZUMAB PEGOL. Cited charge: 179

Refusal Details

Date
November 4, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
58SCP06 CERTOLIZUMAB PEGOL
Charges
179

Recent inspections

  • 1320018 (OAI Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155229 (VAI Fri Oct 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090360 (VAI Wed May 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003363 (VAI Wed Mar 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928559 (NAI Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources