701792

Philips North America, LLC — FEI 1218950

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 14, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Andover, MA (United States)

Citations

IDCFRDescription
1471821 CFR 820.30(g)Design validation - Risk analysis
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation
407021 CFR 820.30(g)Design validation - documentation
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.