900538

TreyMed, Inc. — FEI 3003007937

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 21, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Sussex, WI (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
45421 CFR 820.40(a)Document review, approval by designated individual