Home / Import refusals / 799-3973714-5/11/1

FDA Import Refusal 799-3973714-5/11/1 — Philips North America, LLC

Philips North America, LLC — FEI 1218950

The FDA refused shipment 799-3973714-5/11/1 from Philips North America, LLC (United States) on October 25, 2024. The refused product falls under Devices — OVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR. Cited charges: 118,3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 25, 2024
Country
United States
Product Category
Devices
Product Code
74NSA OVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR
Charges
118,3280,341

Recent inspections

  • 1073570 (OAI Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 932660 (OAI Thu Jun 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 860079 (OAI Thu Dec 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 747102 (NAI Wed Sep 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701792 (NAI Tue Dec 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-5736092-4/10001/1 (Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Radiological Health)
  • 799-5972947-7/11/1 (Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8986797-3/11/1 (Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-4257990-5/11/1 (Mon Apr 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8850087-0/11/1 (Thu Oct 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources