953257

Renner & Co — FEI 3009968493

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 21, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Cary, IL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
230221 CFR 820.20(e)Quality System Procedures
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
50221 CFR 820.60Identification procedures, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures