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FDA Import Refusal AEK-0318045-8/1/1 — Solara Active Pharma Sciences Limited

Solara Active Pharma Sciences Limited — FEI 3003585876

The FDA refused shipment AEK-0318045-8/1/1 from Solara Active Pharma Sciences Limited (India) on December 17, 2012. The refused product falls under Drugs and Biologics — COLESEVELAM HYDROCHLORIDE (ANTI-HYPERLIPIDEMIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 17, 2012
Country
India
Product Category
Drugs and Biologics
Product Code
62BCS13 COLESEVELAM HYDROCHLORIDE (ANTI-HYPERLIPIDEMIC)
Charges
75

Recent inspections

  • 1217304 (NAI Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123376 (OAI Sat Mar 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012921 (NAI Fri Apr 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888196 (VAI Fri Jun 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 719450 (VAI Fri Apr 08 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 879-4083013-3/10003/1 (Tue Apr 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-9834117-9/21/1 (Tue Oct 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-9834117-9/11/1 (Tue Oct 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 334-2785489-9/11/1A (Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 002-1200075-6/1/1 (Thu Aug 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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