806237

Vilex in Tennessee, Inc. — FEI 1051526

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 1, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Mcminnville, TN (United States)

Citations

IDCFRDescription
243021 CFR 820.30(b)Design plans - Lack of or inadequate
255721 CFR 820.30(c)Design input - documentation
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
310221 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures