Home / Import refusals / HTD-9350980-2/102/1

FDA Import Refusal HTD-9350980-2/102/1 — DRG Instruments GmbH

DRG Instruments GmbH — FEI 3002800697

The FDA refused shipment HTD-9350980-2/102/1 from DRG Instruments GmbH (Germany) on July 8, 2025. The refused product falls under Devices — ENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2. Cited charge: 508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 8, 2025
Country
Germany
Product Category
Devices
Product Code
83MYF ENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2
Charges
508

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-9350980-2/22/1 (Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • HTD-9350980-2/12/1 (Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources