Home / Inspections / 1301914

1301914

BioSensics LLC — FEI 3010331770

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 9, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Newton, MA (United States)

Facility

Other inspections at this facility

  • 1202256 (VAI Fri Apr 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044469 (VAI Fri Mar 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23098ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
23236ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
23255ISO 13485:2016 Clause 8.5.2Corrective action not taken