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Samsung Bioepis Co., Ltd. — FDA Facility Profile

FEI 3010031951

Samsung Bioepis Co., Ltd. is an FDA-registered facility (FEI 3010031951) located in South (KOR). Registered operations: ANALYSIS. RegDataLab tracks 4 FDA inspections at this facility.

Facility Details

Location
South (KOR)
Registration Expires
December 31, 2026
Operations
ANALYSIS
Source
decrs

Recent inspections

  • 1255085 (VAI Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1217751 (VAI Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085327 (NAI Fri Feb 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988922 (VAI Fri Aug 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • NSA-0032187-7/10002/1 (Mon Jun 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources