Home / Import refusals / AEK-5354644-3/131/1

FDA Import Refusal AEK-5354644-3/131/1 — Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. — FEI 1219913

The FDA refused shipment AEK-5354644-3/131/1 from Siemens Healthcare Diagnostics, Inc. (United States) on December 4, 2018. The refused product falls under Devices — HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY). Cited charges: 16,479 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 4, 2018
Country
United States
Product Category
Devices
Product Code
83LOL HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
Charges
16,479

Recent inspections

  • 1163970 (VAI Tue Mar 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1043709 (VAI Fri Mar 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018565 (VAI Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929757 (NAI Wed May 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821920 (NAI Wed Feb 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-5354644-3/101/1 (Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-5354644-3/61/1 (Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-5354644-3/121/1 (Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-5354644-3/51/1 (Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-5354644-3/81/1 (Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources