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FDA Inspection 1211451 — Pentax of America Inc

Pentax of America Inc — FEI 1000080301

The FDA completed an inspection of Pentax of America Inc on July 20, 2023 in Montvale, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 20, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Montvale, NJ (United States)

Facility

Other inspections at this facility

  • 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))

Recent compliance actions

FDA data resources