Home / Import refusals / EI5-0070787-9/11/1

FDA Import Refusal EI5-0070787-9/11/1 — P.T. Sankei Medical Industries

P.T. Sankei Medical Industries — FEI 3001576493

The FDA refused shipment EI5-0070787-9/11/1 from P.T. Sankei Medical Industries (Indonesia) on April 1, 2024. The refused product falls under Devices — SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. Cited charges: 118,16,3280,3904 This firm has 4 other import refusals on record.

Refusal Details

Date
April 1, 2024
Country
Indonesia
Product Category
Devices
Product Code
74DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Charges
118,16,3280,3904

Recent inspections

  • 1207456 (OAI Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969061 (VAI Thu Apr 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • EI5-0070787-9/21/1 (Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • EI5-0070787-9/31/1 (Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • EI5-0070787-9/41/1 (Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • EI5-0070787-9/51/1 (Mon Apr 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources