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FDA Import Refusal AMN-0103137-2/232/1D — CSPC Ouyi Pharmaceutical Co., Ltd.

CSPC Ouyi Pharmaceutical Co., Ltd. — FEI 2000021110

The FDA refused shipment AMN-0103137-2/232/1D from CSPC Ouyi Pharmaceutical Co., Ltd. (China) on May 14, 2025. The refused product falls under Drugs and Biologics — AZITHROMYCIN (MACAROLIDES). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 14, 2025
Country
China
Product Category
Drugs and Biologics
Product Code
56IDC76 AZITHROMYCIN (MACAROLIDES)
Charges
75

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))

Other import refusals

  • 1FX-0717684-5/10002/1C (Mon Jun 08 2026 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-8721320-0/21/1 (Wed Feb 10 2021 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)

FDA data resources