Home / Import refusals / HTD-9350980-2/12/1

FDA Import Refusal HTD-9350980-2/12/1 — DRG Instruments GmbH

DRG Instruments GmbH — FEI 3002800697

The FDA refused shipment HTD-9350980-2/12/1 from DRG Instruments GmbH (Germany) on July 8, 2025. The refused product falls under Devices — ASSAY, ENZYME LINKED IMMUNOSORBENT, PARVOVIRUS B19 IGG. Cited charge: 237 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 8, 2025
Country
Germany
Product Category
Devices
Product Code
83MYL ASSAY, ENZYME LINKED IMMUNOSORBENT, PARVOVIRUS B19 IGG
Charges
237

Recent inspections

  • 1254938 (OAI Thu Nov 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999374 (OAI Fri Oct 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 846339 (NAI Thu Aug 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699317 (VAI Thu Oct 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • HTD-9350995-0/22/1 (Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • HTD-9350937-2/22/1 (Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • HTD-9350953-9/181/1 (Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • HTD-9350980-2/32/1 (Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • HTD-9350980-2/22/1 (Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources