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FDA Import Refusal 336-4901280-0/20001/1 — Lumitex Medical Devices Inc

Lumitex Medical Devices Inc — FEI 1000122810

The FDA refused shipment 336-4901280-0/20001/1 from Lumitex Medical Devices Inc (United States) on July 9, 2026. The refused product falls under Devices — UNIT, NEONATAL PHOTOTHERAPY. Cited charge: 118

Refusal Details

Date
July 9, 2026
Country
United States
Product Category
Devices
Product Code
80LBI UNIT, NEONATAL PHOTOTHERAPY
Charges
118

Recent inspections

  • 1315326 (VAI Fri May 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1000208 (NAI Mon Jan 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859893 (NAI Thu Dec 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730676 (NAI Wed Jun 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources