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CSPC Ouyi Pharmaceutical Co., Ltd. — FDA Facility Profile

FEI 2000021110

CSPC Ouyi Pharmaceutical Co., Ltd. is an FDA-registered facility (FEI 2000021110) located in Hebei 052160, CN. Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections at this facility.

Facility Details

Location
Hebei 052160 (CN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1239361 (VAI Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036247 (NAI Fri Oct 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021148 (VAI Wed Aug 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945964 (VAI Fri Sep 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946065 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928785 (VAI Tue May 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 877908 (VAI Thu Apr 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 808380 (NAI Thu Nov 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 1FX-0717684-5/10002/1C (Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AMN-0103137-2/232/1D (Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8349370-8/12/1 (Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4824282-8/41/1 (Tue Apr 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8721320-0/11/1 (Wed Feb 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8721320-0/21/1 (Wed Feb 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6809312-8/11/3 (Wed May 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • M21-0752328-6/2/1 (Fri Jul 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • M21-0752328-6/1/1 (Fri Jul 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • M21-0752328-6/3/1 (Fri Jul 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources