1114919

Philips Respironics, Inc. — FEI 2518422

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 10, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Murrysville, PA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction