886993

AccessClosure, Inc., A Cardinal Health Company — FEI 3010142363

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 5, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Santa Clara, CA (United States)

Citations

IDCFRDescription
53721 CFR 820.70(a)Production processes
54621 CFR 820.75(a)Lack of or inadequate process validation
73221 CFR 803.50(a)(2)Individual Report of Malfunction