574101

A&D Company Manufacturing, Ltd. — FEI 3006899423

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 19, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Shimotsuma (Japan)

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
319121 CFR 820.30(g)Design validation - production units
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
407021 CFR 820.30(g)Design validation - documentation