Home / Import refusals / 399-1113959-8/11/1

FDA Import Refusal 399-1113959-8/11/1 — Hologic, Inc.

Hologic, Inc. — FEI 1220984

The FDA refused shipment 399-1113959-8/11/1 from Hologic, Inc. (United States) on May 24, 2024. The refused product falls under Devices — SYSTEM, X-RAY, MAMMOGRAPHIC. Cited charge: 341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 24, 2024
Country
United States
Product Category
Devices
Product Code
90IZH SYSTEM, X-RAY, MAMMOGRAPHIC
Charges
341

Recent inspections

  • 1019474 (VAI Fri Jul 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007334 (NAI Tue Apr 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878443 (VAI Fri Apr 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 785328 (NAI Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701114 (VAI Wed Dec 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AWM-0041862-6/11/1 (Mon Jul 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-9500457-1/2/1 (Wed Jan 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 905-1007202-9/2/1 (Thu Dec 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0061904-2/1/1 (Mon Jan 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9607743-5/1/1 (Wed Dec 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources