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Rottendorf Pharma GmbH — FDA Facility Profile

FEI 3003732290

Rottendorf Pharma GmbH is an FDA-registered facility (FEI 3003732290) located in Ennigerloh, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

Facility Details

Location
Ennigerloh (DE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1303578 (VAI Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247046 (VAI Thu May 06 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083771 (VAI Thu Feb 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005464 (VAI Fri Feb 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875352 (NAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779560 (VAI Fri Mar 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-0593779-1/10002/9 (Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9362796-4/10002/1 (Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9791643-5/10003/1 (Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7887918-4/10002/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7253524-6/12/1 (Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7320062-6/22/1 (Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7248433-8/52/1 (Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8505357-9/12/1 (Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8419521-1/11/1 (Tue Apr 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8223074-7/21/1 (Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources