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SM BIOMED SDN.BHD. — FDA Facility Profile

FEI 3005983287

SM BIOMED SDN.BHD. is an FDA-registered facility (FEI 3005983287) located in Malaysia (MYS). Registered operations: API MANUFACTURE. RegDataLab tracks 4 FDA inspections at this facility.

Facility Details

Location
Malaysia (MYS)
Registration Expires
December 31, 2026
Operations
API MANUFACTURE
Source
decrs

Recent inspections

  • 1215468 (VAI Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1048456 (VAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 972744 (VAI Fri Mar 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821162 (VAI Thu Mar 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-6449271-5/11/1 (Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0422958-6/1/1 (Tue Nov 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources