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FDA Import Refusal AV3-0023106-3/1/1 — Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. — FEI 2517506

The FDA refused shipment AV3-0023106-3/1/1 from Siemens Healthcare Diagnostics, Inc. (United States) on December 30, 2010. The refused product falls under Devices — PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS. Cited charges: 118,341,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 30, 2010
Country
United States
Product Category
Devices
Product Code
82LTJ PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Charges
118,341,508

Recent inspections

  • 875518 (VAI Wed Apr 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 813459 (NAI Mon Dec 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768876 (OAI Thu Feb 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 585525 (VAI Fri May 08 2009 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