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FDA Import Refusal 113-5235526-4/1/1B — Keshava Organics Private Ltd.

Keshava Organics Private Ltd. — FEI 3003677831

The FDA refused shipment 113-5235526-4/1/1B from Keshava Organics Private Ltd. (India) on August 13, 2010. The refused product falls under Drugs and Biologics — BROMPHENIRAMINE MALEATE (ANTI-HISTAMINIC). Cited charge: 16 This firm has 3 other import refusals on record.

Refusal Details

Date
August 13, 2010
Country
India
Product Category
Drugs and Biologics
Product Code
61XCS04 BROMPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
Charges
16

Recent inspections

  • 1197238 (VAI Fri Jan 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021757 (OAI Wed May 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878344 (OAI Fri Apr 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 733263 (VAI Tue May 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • OHL-0422599-5/1/1 (Tue Jan 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • OHL-0422599-5/2/1 (Tue Jan 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-0369383-8/1/1 (Fri Mar 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources