Home / Import refusals / 855-0046222-2/45/1

FDA Import Refusal 855-0046222-2/45/1 — Professional Disposables International, Inc.

Professional Disposables International, Inc. — FEI 2411192

The FDA refused shipment 855-0046222-2/45/1 from Professional Disposables International, Inc. (United States) on March 6, 2014. The refused product falls under Devices — GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE. Cited charges: 118,186,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 6, 2014
Country
United States
Product Category
Devices
Product Code
79NAB GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE
Charges
118,186,3280

Recent inspections

  • 1310208 (VAI Tue Mar 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1236000 (NAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1146961 (OAI Wed Jun 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1040815 (VAI Fri Dec 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951891 (VAI Wed Dec 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • EI5-5568707-4/1/1 (Tue Aug 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • BJV-0241774-0/65/3 (Wed Aug 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BJV-0242255-9/13/1 (Wed Aug 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BJV-0241005-9/63/2 (Tue Jun 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BJV-0240964-8/4/1 (Fri Jun 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources