578052

Designs For Vision, Inc. — FEI 2431764

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 19, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Bohemia, NY (United States)

Citations

IDCFRDescription
260221 CFR 820.30(d)Design output - review and approval
310221 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
323521 CFR 820.72(a)Equipment control activity documentation
327021 CFR 820.80(c)Documentation
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
367321 CFR 820.30(c)Design input approval documentation