557428

Sendx Medical Inc — FEI 2027541

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 20, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Compliance: Devices
Location
Carlsbad, CA (United States)

Citations

IDCFRDescription
326321 CFR 820.250(b)Sampling plans
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
53821 CFR 820.70(a)Process control procedures
54021 CFR 820.70(b)Production and process changes - failure to follow procedure
73221 CFR 803.50(a)(2)Individual Report of Malfunction