980930

Surgisil, LLP — FEI 3006007116

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 29, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Plano, TX (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
237121 CFR 820.30(a)Design control - no procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures