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Roche Diagnostics GmbH — FDA Facility Profile

FEI 3002806559

Roche Diagnostics GmbH is an FDA-registered facility (FEI 3002806559) located in MANNHEIM Baden-Wurttemberg, DE. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
MANNHEIM Baden-Wurttemberg (DE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
both

Recent inspections

  • 1177109 (VAI Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103444 (VAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057452 (NAI Thu Apr 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993103 (NAI Fri Nov 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973782 (NAI Fri Apr 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928460 (NAI Wed May 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874281 (VAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859902 (NAI Wed Dec 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801600 (NAI Thu Sep 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 780147 (VAI Thu Apr 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • EMO-0483555-0/10002/1 (Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-1899088-1/110002/1 (Thu Dec 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-1899088-1/120002/1 (Thu Dec 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9637208-5/11/1C (Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9637208-5/11/1D (Fri May 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-2576777-8/11/1 (Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-3240751-6/21/1 (Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0145400-7/11/1 (Wed Feb 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-7731982-8/11/1 (Thu Oct 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SG5-0437865-7/11/1 (Fri May 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources