653183

Fenwal International, Inc. — FEI 2627511

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 23, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Maricao, PR (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
241921 CFR 211.198(a)Complaint Handling Procedure
440221 CFR 211.192Written record of investigation incomplete