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1181701

BioSculptor Corporation — FEI 1000560772

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 19, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Hialeah, FL (United States)

Facility

Other inspections at this facility

  • 1120660 (VAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945758 (NAI Tue Oct 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 739588 (VAI Tue Aug 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699614 (VAI Tue Nov 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699615 (NAI Tue Nov 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures