Home / Inspections / 1151497

1151497

Philips Respironics, Inc. — FEI 2518422

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 10, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Murrysville, PA (United States)

Facility

Other inspections at this facility

  • 1170199 (VAI Thu May 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156266 (OAI Tue Nov 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114919 (OAI Fri Jan 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056962 (OAI Mon May 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 954800 (OAI Fri Jan 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures