1059209

Richard Wolf Medical Instruments Corp. — FEI 1418479

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 17, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Vernon Hills, IL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
320321 CFR 820.40(b)Document change records, maintained.
323521 CFR 820.72(a)Equipment control activity documentation
41921 CFR 820.20(b)Lack of or inadequate organizational structure
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures