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Antibiotice SA — FDA Facility Profile

FEI 3003489017

Antibiotice SA is an FDA-registered facility (FEI 3003489017) located in Romania (ROU). Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

Facility Details

Location
Romania (ROU)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; MANUFACTURE
Source
decrs

Recent inspections

  • 1245118 (VAI Fri Oct 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136125 (VAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007402 (VAI Tue Mar 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818053 (NAI Tue Jan 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 713355 (VAI Tue Nov 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • SCS-3506984-0/11/3 (Fri Jan 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2613212-6/1/1A (Tue Aug 22 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources