793050

XTANT Medical Holdings, Inc — FEI 3005031160

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 27, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Belgrade, MT (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
320121 CFR 820.40(a)Not approved or obsolete document retrieval
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures