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Facilities
/ 3002806419
Simtra Deutschland GmbH
FEI 3002806419
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
Warning Letter (720436)
(Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
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)
Facility Details
Location
33790 (DE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION; STERILIZE
Source
decrs