1022863

Vilex in Tennessee, Inc. — FEI 1051526

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 25, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Mcminnville, TN (United States)

Citations

IDCFRDescription
1471821 CFR 820.30(g)Design validation - Risk analysis
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
310421 CFR 820.30(j)Design history file
368621 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures