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FDA Import Refusal EG6-3159327-4/2/1 — Apotex Pharmachem India Pvt Ltd.

Apotex Pharmachem India Pvt Ltd. — FEI 3005466325

The FDA refused shipment EG6-3159327-4/2/1 from Apotex Pharmachem India Pvt Ltd. (India) on September 17, 2014. The refused product falls under Drugs and Biologics — ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 17, 2014
Country
India
Product Category
Drugs and Biologics
Product Code
62ODC28 ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II)
Charges
27

Recent inspections

  • 1263710 (VAI Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180313 (NAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118806 (VAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057873 (VAI Tue Jun 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978926 (VAI Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • EG6-3197344-3/1/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3159327-4/1/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3176162-4/1/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821732-7/1/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821731-9/1/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources