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FDA Inspection 921077 — Pentax of America Inc

Pentax of America Inc — FEI 1000080301

The FDA completed an inspection of Pentax of America Inc on April 2, 2015 in Montvale, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 2, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Montvale, NJ (United States)

Facility

Other inspections at this facility

  • 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))
  • 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))

Recent compliance actions

FDA data resources