Home / Import refusals / F23-9339758-3/60002/1

FDA Import Refusal F23-9339758-3/60002/1 — Swords Laboratories Unlimited Company

Swords Laboratories Unlimited Company — FEI 3004531790

The FDA refused shipment F23-9339758-3/60002/1 from Swords Laboratories Unlimited Company (Ireland) on September 3, 2025. The refused product falls under Drugs and Biologics — NIVOLUMAB. Cited charge: 75 This firm has 2 other import refusals on record.

Refusal Details

Date
September 3, 2025
Country
Ireland
Product Category
Drugs and Biologics
Product Code
58DCY41 NIVOLUMAB
Charges
75

Recent inspections

  • 1224780 (NAI Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067641 (NAI Wed Jul 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982749 (NAI Tue Jul 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800401 (NAI Thu Sep 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-9953903-6/10002/1 (Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9339758-3/100002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources