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PENTAX of America, Inc. — FDA Facility Profile

FEI 1000080301

PENTAX of America, Inc. is an FDA-registered facility (FEI 1000080301) located in MONTVALE, NJ, US. RegDataLab tracks 7 FDA inspections and 2 compliance actions at this facility.

Facility Details

Location
MONTVALE, NJ (US)
Registration Expires
N/A
Operations
Source
device

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))
  • 718354 (VAI Thu Mar 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 583525 (NAI Mon May 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 799-6436376-7/11/1 (Wed Mar 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 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