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HELSINN BIREX PHARMACEUTICALS LIMITED — FDA Facility Profile

FEI 3003724414

HELSINN BIREX PHARMACEUTICALS LIMITED is an FDA-registered facility (FEI 3003724414) located in D15 X925, IE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

Facility Details

Location
D15 X925 (IE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1272910 (VAI Fri Jul 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123956 (VAI Fri Oct 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973919 (NAI Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 887344 (NAI Fri Feb 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710425 (VAI Thu May 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • SCS-2999734-4/11/2 (Wed Jan 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5611352-1/1/1 (Tue Jun 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-5713080-1/1/1 (Fri Sep 14 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources