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1294938

Foresight Imaging, LLC — FEI 3003063996

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 12, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Chelmsford, MA (United States)

Facility

Other inspections at this facility

  • 1194465 (VAI Tue Dec 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023886 (VAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 810782 (NAI Wed Dec 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 658431 (VAI Tue Apr 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures