Home / Import refusals / 799-5036978-4/11/1

FDA Import Refusal 799-5036978-4/11/1 — Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited — FEI 3007501748

The FDA refused shipment 799-5036978-4/11/1 from Alembic Pharmaceuticals Limited (India) on October 12, 2021. The refused product falls under Drugs and Biologics — TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 12, 2021
Country
India
Product Category
Drugs and Biologics
Product Code
62HCA03 TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL)
Charges
75

Recent inspections

  • 1267871 (NAI Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055638 (VAI Fri May 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927526 (VAI Thu Apr 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 830941 (VAI Fri Apr 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712407 (NAI Thu Feb 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-3185386-5/11/4 (Tue Feb 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1252035-7/41/1 (Thu Jun 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0023099-3/121/1 (Wed Dec 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2993166-1/21/1 (Wed Mar 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1222018-9/3/1 (Fri May 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources