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574528

Nano-Ditech Corporation — FEI 3005174594

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 7, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Cranbury, NJ (United States)

Facility

Other inspections at this facility

  • 1218856 (NAI Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063763 (NAI Fri Jun 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922362 (NAI Wed Apr 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882198 (VAI Tue Jun 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
315621 CFR 820.181(b)DMR production process specifications
323521 CFR 820.72(a)Equipment control activity documentation
331321 CFR 820.120(d)Records, DHR {see also 820.184(e)}
369121 CFR 820.100(a)(4)Verification vs validation
44721 CFR 820.40Lack of procedures, or not maintained