546595

Summit Industries Inc. — FEI 1450503

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 10, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Niles, IL (United States)

Citations

IDCFRDescription
227921 CFR 820.20(b)(2)Resources
229321 CFR 820.20(d)Quality plan
320421 CFR 820.40(b)Change records, content
366721 CFR 820.20(c)Management review accomplishment
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
367121 CFR 820.25(a)Personnel
369021 CFR 820.100(a)(3)Identification of actions needed
54021 CFR 820.70(b)Production and process changes - failure to follow procedure