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1144696

Magellan Diagnostics, Inc. — FEI 1218996

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 22, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
North Billerica, MA (United States)

Facility

Other inspections at this facility

  • 1280392 (OAI Tue Aug 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107302 (VAI Mon Oct 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016218 (OAI Thu Jun 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884803 (NAI Wed Jun 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 765692 (VAI Thu Feb 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
54621 CFR 820.75(a)Lack of or inadequate process validation