Home / Import refusals / 799-9480084-6/11/1

FDA Import Refusal 799-9480084-6/11/1 — Aurobindo Pharma USA Inc

Aurobindo Pharma USA Inc — FEI 3008460374

The FDA refused shipment 799-9480084-6/11/1 from Aurobindo Pharma USA Inc (United States) on August 11, 2025. The refused product falls under Drugs and Biologics — ROSUVASTATIN CALCIUM. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 11, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
61JDY16 ROSUVASTATIN CALCIUM
Charges
75

Recent inspections

  • 1238442 (OAI Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 908515 (NAI Fri Dec 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 783745 (NAI Wed May 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 736360 (VAI Fri Jul 29 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-6671732-3/11/9 (Mon Jan 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6671732-3/11/3 (Mon Jan 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6671732-3/11/11 (Mon Jan 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8280400-5/11/1 (Wed Aug 26 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7064234-0/11/1 (Fri Apr 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources