Home / Import refusals / 799-6436376-7/11/1

FDA Import Refusal 799-6436376-7/11/1 — Pentax of America Inc

Pentax of America Inc — FEI 1000080301

The FDA refused shipment 799-6436376-7/11/1 from Pentax of America Inc (United States) on March 5, 2025. The refused product falls under Devices — DUODEDOSCOPE, ESOPHAGO GASTRO. Cited charges: 118,3280,341 This firm has 3 other import refusals on record.

Refusal Details

Date
March 5, 2025
Country
United States
Product Category
Devices
Product Code
78FDT DUODEDOSCOPE, ESOPHAGO GASTRO
Charges
118,3280,341

Recent inspections

  • 1211451 (NAI Thu Jul 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066901 (VAI Thu Sep 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921077 (OAI Thu Apr 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906155 (VAI Wed Dec 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812553 (OAI Tue Dec 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • E8L-1005779-7/1/1 (Wed Jun 10 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • E84-0058192-0/1/1 (Tue Nov 25 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • E84-0058192-0/1/2 (Tue Nov 25 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources