988508

International Medsurg Connection, Inc. — FEI 3000210101

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 16, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Schaumburg, IL (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
73221 CFR 803.50(a)(2)Individual Report of Malfunction