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835336

Olympus Corporation of the Americas — FEI 2429304

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Center Valley, PA (United States)

Facility

Other inspections at this facility

  • 1107356 (NAI Thu Sep 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920723 (NAI Wed Apr 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793907 (OAI Thu Aug 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709142 (NAI Thu Feb 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
73321 CFR 803.50(b)(1)Reporting Information Reasonably Known