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FDA Import Refusal F23-9238574-6/11/1 — Fleming Laboratories Limited

Fleming Laboratories Limited — FEI 3007931994

The FDA refused shipment F23-9238574-6/11/1 from Fleming Laboratories Limited (India) on March 19, 2020. The refused product falls under Drugs and Biologics — HYDROXYZINE HCL (TRANQUILIZER). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 19, 2020
Country
India
Product Category
Drugs and Biologics
Product Code
66MRR83 HYDROXYZINE HCL (TRANQUILIZER)
Charges
27

Recent inspections

  • 1012855 (OAI Tue May 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • M21-0751674-4/1/1 (Fri Apr 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • M21-0749653-3/1/1 (Fri Mar 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9056206-4/1/1 (Fri Jan 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 411-8326176-1/1/1 (Thu Dec 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 020-0168926-0/1/1 (Tue Feb 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources