800282

J&T Health and Wellness LLC — FEI 1000525872

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 21, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Saint Petersburg, FL (United States)

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
420821 CFR 806.20(a)Records not kept