Home / Import refusals / AEK-8596954-8/11/1

FDA Import Refusal AEK-8596954-8/11/1 — Syntron Bioresearch Inc

Syntron Bioresearch Inc — FEI 2025760

The FDA refused shipment AEK-8596954-8/11/1 from Syntron Bioresearch Inc (United States) on January 15, 2021. The refused product falls under Devices — REAGENT, CORONAVIRUS SEROLOGICAL. Cited charge: 508 This firm has 2 other import refusals on record.

Refusal Details

Date
January 15, 2021
Country
United States
Product Category
Devices
Product Code
83QKO REAGENT, CORONAVIRUS SEROLOGICAL
Charges
508

Recent inspections

  • 1271569 (VAI Mon Jun 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155123 (VAI Thu Oct 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981497 (VAI Fri Jul 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 717354 (VAI Fri Apr 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 700797 (OAI Tue Nov 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-7680504-2/11/1 (Sat Aug 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7941267-0/12/1 (Tue Dec 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources