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FDA Import Refusal 799-5335062-6/11/1 — Shandong Xinhua Pharmaceutical Co., Ltd. First Plant

Shandong Xinhua Pharmaceutical Co., Ltd. First Plant — FEI 3002808153

The FDA refused shipment 799-5335062-6/11/1 from Shandong Xinhua Pharmaceutical Co., Ltd. First Plant (China) on June 29, 2023. The refused product falls under Drugs and Biologics — IBUPROFEN (ANTI-INFLAMMATORY). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 29, 2023
Country
China
Product Category
Drugs and Biologics
Product Code
62GAS41 IBUPROFEN (ANTI-INFLAMMATORY)
Charges
118

Recent inspections

  • 1220079 (NAI Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1000050 (NAI Thu Mar 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875678 (VAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 685447 (NAI Tue Jul 13 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • BUU-1233351-0/11/1 (Wed Sep 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 109-0920879-4/1/2 (Tue Sep 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 109-0920879-4/1/1 (Tue Sep 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-0099425-4/1/1 (Fri Oct 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • W69-4080230-0/1/1 (Fri Jan 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources