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1071458

Bio-Signal Group Corp. — FEI 3006315274

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 9, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Acton, MA (United States)

Facility

Other inspections at this facility

  • 1178459 (VAI Tue Aug 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118219 (VAI Wed Feb 19 2020 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
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
233921 CFR 820.22Quality Audit/Reaudit - documentation
311521 CFR 820.70(h)Use and removal, Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
366821 CFR 820.20(c)Management review dates
369621 CFR 820.100(b)Documentation