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FDA Import Refusal 231-4988945-8/41/2 — Acme United Corporation

Acme United Corporation — FEI 1030186

The FDA refused shipment 231-4988945-8/41/2 from Acme United Corporation (United States) on December 6, 2017. The refused product falls under Drugs and Biologics — BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 6, 2017
Country
United States
Product Category
Drugs and Biologics
Product Code
55QY41 BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE)
Charges
118

Recent inspections

  • 1280222 (NAI Wed Aug 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086685 (VAI Thu Apr 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009155 (VAI Tue Apr 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965675 (NAI Thu Feb 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773700 (VAI Wed Mar 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-7840244-4/21/2 (Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7840244-4/21/1 (Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7840244-4/21/3 (Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7840244-4/31/1 (Thu Nov 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-4988945-8/31/1 (Wed Dec 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources