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FDA Warning Letter — Pentax of America Inc

Case 461516 — FEI 1000080301

The FDA took a Warning Letter action against Pentax of America Inc on August 12, 2015 (Montvale, NJ). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Pentax of America Inc
Date
August 12, 2015
Fiscal Year
2015
Product Type
Devices
Center
CDRH
Location
Montvale, NJ (United States)

Facility

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))

Other compliance actions

FDA data resources