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718354

Pentax of America Inc — FEI 1000080301

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 17, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: 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))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
337521 CFR 820.198(e)Records of complaint investigation
45421 CFR 820.40(a)Document review, approval by designated individual