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Simtra Deutschland GmbH — FDA Facility Profile

FEI 3002806419

Simtra Deutschland GmbH is an FDA-registered facility (FEI 3002806419) located in Halle/Westfalen, DE. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION; STERILIZE. RegDataLab tracks 10 or more FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Halle/Westfalen (DE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION; STERILIZE
Source
decrs

Recent inspections

  • 1283802 (OAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206312 (NAI Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161093 (VAI Wed Jan 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106642 (NAI Tue Sep 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056958 (VAI Thu Jun 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019700 (VAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967376 (VAI Fri Mar 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888909 (NAI Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 845264 (NAI Sat Jul 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 747007 (NAI Fri Aug 26 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • KH5-4149876-3/11/1 (Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • KH5-4149876-3/21/1 (Thu Jul 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-8256709-5/11/1 (Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0928632-7/11/1 (Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0928632-7/31/1 (Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7007892-4/1/1 (Thu Dec 09 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6994993-7/1/1 (Thu Oct 14 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources