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FDA Import Refusal 655-2005109-9/11/3 — Teva API India Private Ltd.

Teva API India Private Ltd. — FEI 3005343793

The FDA refused shipment 655-2005109-9/11/3 from Teva API India Private Ltd. (India) on April 6, 2017. The refused product falls under Drugs and Biologics — MONTELUKAST SODIUM (ANTI-ASTHMATIC). Cited charge: 16 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 6, 2017
Country
India
Product Category
Drugs and Biologics
Product Code
61ECS09 MONTELUKAST SODIUM (ANTI-ASTHMATIC)
Charges
16

Recent inspections

  • 1210251 (VAI Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044289 (VAI Fri Feb 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933418 (NAI Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793027 (VAI Wed Jun 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 571559 (NAI Fri Feb 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 655-2017855-3/11/1 (Fri Oct 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 655-2017855-3/11/2 (Fri Oct 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 655-2017856-1/11/1 (Fri Oct 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 655-2017856-1/11/2 (Fri Oct 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 655-2017856-1/11/3 (Fri Oct 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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