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1092549

Rinovum Subsidiary 2 LLC — FEI 3015417614

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 11, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Monroeville, PA (United States)

Facility

Other inspections at this facility

  • 1218022 (VAI Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1037949 (NAI Fri Nov 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019524 (NAI Thu May 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate