966715

W & R Investments LLC d.b.a. Laser Engineering — FEI 3009593803

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 13, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Milford, MA (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
319221 CFR 820.30(g)Design validation - user needs and intended uses
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
341521 CFR 820.22Quality Audit/Reaudit - conducted
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.