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1178459

Bio-Signal Group Corp. — FEI 3006315274

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Acton, MA (United States)

Facility

Other inspections at this facility

  • 1118219 (VAI Wed Feb 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071458 (VAI Fri Nov 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936931 (VAI Tue Jul 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769843 (VAI Mon Feb 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
316021 CFR 820.184Lack of or inadequate DHR procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures