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FDA Import Refusal K51-0086045-8/1/1 — Philips North America LLC

Philips North America LLC — FEI 1000524572

The FDA refused shipment K51-0086045-8/1/1 from Philips North America LLC (United States) on September 9, 2016. The refused product falls under Devices — AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE). Cited charges: 3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 9, 2016
Country
United States
Product Category
Devices
Product Code
74MKJ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Charges
3280,341

Recent inspections

  • 1182153 (VAI Thu Oct 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149323 (VAI Fri Aug 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121760 (NAI Wed Mar 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073302 (OAI Mon Dec 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923916 (OAI Tue Apr 21 2015 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)
  • 799-3973714-5/11/1 (Fri Oct 25 2024 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)

FDA data resources