Home / Inspections / 760152

760152

Acclarent, Inc. — FEI 3005172759

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 24, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1131271 (NAI Fri Sep 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 858416 (NAI Mon Dec 09 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 817537 (OAI Fri Feb 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
319221 CFR 820.30(g)Design validation - user needs and intended uses
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate