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1009933

Dynavision Global Holdings LLC — FEI 3010197315

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 26, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Cincinnati, OH (United States)

Facility

Other inspections at this facility

  • 1216483 (NAI Thu Aug 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109742 (NAI Wed Oct 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087784 (NAI Mon Apr 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471721 CFR 820.30(g)Design validation - software validation documentation
310421 CFR 820.30(j)Design history file
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures