Home / Import refusals / AEK-0078519-4/11/1

FDA Import Refusal AEK-0078519-4/11/1 — Prollenium Medical Technologies Inc.

Prollenium Medical Technologies Inc. — FEI 3004423487

The FDA refused shipment AEK-0078519-4/11/1 from Prollenium Medical Technologies Inc. (Canada) on December 19, 2021. The refused product falls under Devices — IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE. Cited charges: 118,237,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 19, 2021
Country
Canada
Product Category
Devices
Product Code
79LMH IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
Charges
118,237,3280

Recent inspections

  • 1070919 (VAI Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011040 (NAI Thu Apr 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-5142103-7/10003/1 (Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0401284-7/11/1 (Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-4236024-9/11/1 (Mon Apr 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0342795-3/11/1 (Wed Sep 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-1005342-2/11/1B (Mon May 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources