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INKE SA — FDA Facility Profile

FEI 3003663245

INKE SA is an FDA-registered facility (FEI 3003663245) located in Castellbisbal, ES. Registered operations: API MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

Facility Details

Location
Castellbisbal (ES)
Registration Expires
December 31, 2026
Operations
API MANUFACTURE
Source
decrs

Recent inspections

  • 1313264 (VAI Wed Mar 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111970 (VAI Wed Apr 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988740 (NAI Fri Apr 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821831 (VAI Fri Jan 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 601782 (VAI Sat Jul 25 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 9ES-0094279-5/10002/1 (Fri Aug 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9ES-0094279-5/20002/1 (Fri Aug 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6247734-2/11/1 (Tue May 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1004893-7/1/1 (Wed Oct 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources