820874

RS Medical — FEI 1000117825

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 15, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Vancouver, WA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317021 CFR 820.198(b)Review and evaluation for investigation
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation