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FDA Import Refusal 300-6007091-9/11/1 — Jilin Shulan Synthetic Pharmaceutical Co. Ltd.

Jilin Shulan Synthetic Pharmaceutical Co. Ltd. — FEI 3003091092

The FDA refused shipment 300-6007091-9/11/1 from Jilin Shulan Synthetic Pharmaceutical Co. Ltd. (China) on March 8, 2018. The refused product falls under Drugs and Biologics — THEOPHYLLINE (BRONCHODILATOR). Cited charge: 16 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 8, 2018
Country
China
Product Category
Drugs and Biologics
Product Code
63BQS30 THEOPHYLLINE (BRONCHODILATOR)
Charges
16

Recent inspections

  • 1032074 (OAI Fri Nov 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921290 (VAI Fri Mar 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 755260 (VAI Wed Nov 30 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 612640 (OAI Fri Aug 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 196-1530512-5/11/1 (Tue Sep 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 196-1530512-5/11/2 (Tue Sep 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 196-1530512-5/11/3 (Tue Sep 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 196-1530512-5/11/4 (Tue Sep 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BSQ-1706564-6/1/1 (Fri Nov 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources