Home / Import refusals / 799-7608597-7/12/1

FDA Import Refusal 799-7608597-7/12/1 — Plexus Manufacturing Sdn. Bhd.

Plexus Manufacturing Sdn. Bhd. — FEI 3004593495

The FDA refused shipment 799-7608597-7/12/1 from Plexus Manufacturing Sdn. Bhd. (Malaysia) on November 15, 2023. The refused product falls under Devices — PULSE-GENERATOR, PACEMAKER, EXTERNAL. Cited charges: 118,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 15, 2023
Country
Malaysia
Product Category
Devices
Product Code
74DTE PULSE-GENERATOR, PACEMAKER, EXTERNAL
Charges
118,341

Recent inspections

  • 1293036 (NAI Thu Nov 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209397 (NAI Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993647 (NAI Wed Nov 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882455 (VAI Thu May 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 789454 (VAI Thu May 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-7608597-7/22/1 (Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 286-6599454-8/11/1 (Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-3797085-5/2/1 (Tue Oct 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 004-5011564-7/1/1 (Thu May 29 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 004-5011517-5/1/1 (Thu May 29 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources