1031705

Genesis BPS, LLC. — FEI 1000527169

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 20, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Ramsey, NJ (United States)

Citations

IDCFRDescription
316821 CFR 820.198(a)Complaints
319121 CFR 820.30(g)Design validation - production units
45421 CFR 820.40(a)Document review, approval by designated individual
63021 CFR 803.17Lack of Written MDR Procedures