1047930

Dukal Llc — FEI 1000137528

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Ronkonkoma, NY (United States)

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
311821 CFR 820.75(a)Documentation
342721 CFR 820.50(a)(2)Supplier oversight
369621 CFR 820.100(b)Documentation
407021 CFR 820.30(g)Design validation - documentation
443721 CFR 803.40(b)Report of malfunction likely to cause death or injury