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Laboratorium Ofichem BV — FDA Facility Profile

FEI 1000286391

Laboratorium Ofichem BV is an FDA-registered facility (FEI 1000286391) located in CZ 9561, NL. Registered operations: API MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

Facility Details

Location
CZ 9561 (NL)
Registration Expires
December 31, 2026
Operations
API MANUFACTURE
Source
decrs

Recent inspections

  • 1277006 (VAI Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108403 (NAI Wed Sep 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 955260 (VAI Thu Dec 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-9161624-9/1/1 (Mon Apr 06 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 110-3034069-1/4/1 (Tue Dec 31 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 110-3868885-8/1/1 (Tue Jan 22 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources