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FDA Inspection 1193763 — Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. — FEI 1823260

The FDA completed an inspection of Roche Diagnostics Operations, Inc. on December 7, 2022 in Indianapolis, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 7, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Indianapolis, IN (United States)

Facility

Other inspections at this facility

  • 1094392 (VAI Thu Jun 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988860 (NAI Fri Oct 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984591 (VAI Mon Aug 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934927 (NAI Tue Jul 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 807515 (NAI Wed Oct 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources