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Roche Diagnostics Operations, Inc. — FDA Facility Profile

FEI 1823260

Roche Diagnostics Operations, Inc. is an FDA-registered facility (FEI 1823260) located in Indianapolis, IN, US. RegDataLab tracks 9 FDA inspections at this facility.

Facility Details

Location
Indianapolis, IN (US)
Registration Expires
N/A
Operations
Source
inspections

Recent inspections

  • 1193763 (NAI Wed Dec 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 755106 (VAI Wed Nov 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 711458 (NAI Fri Jan 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 675382 (NAI Thu Jun 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-1221399-4/1/1 (Fri May 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 322-0669900-5/1/1 (Wed Mar 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9657397-9/1/1 (Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9856844-9/1/1 (Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 110-0403890-1/1/1 (Mon May 16 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 110-0641251-8/1/1 (Mon May 16 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 110-0641174-2/1/1 (Mon May 16 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 582-8338381-9/1/1 (Wed Dec 22 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-6441435-8/1/1 (Sat Oct 23 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AV3-0014975-2/1/1 (Thu Aug 19 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources