Home / Import refusals / 799-1732716-7/10002/1

FDA Import Refusal 799-1732716-7/10002/1 — Mylan Laboratories Limited (FDF-2)

Mylan Laboratories Limited (FDF-2) — FEI 3008316970

The FDA refused shipment 799-1732716-7/10002/1 from Mylan Laboratories Limited (FDF-2) (India) on October 7, 2025. The refused product falls under Drugs and Biologics — ABACAVIR SULFATE; DOLUTEGRAVIR; LAMIVUDINE (ANTI-VIRAL). Cited charge: 75 This firm has 4 other import refusals on record.

Refusal Details

Date
October 7, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
62VDY66 ABACAVIR SULFATE; DOLUTEGRAVIR; LAMIVUDINE (ANTI-VIRAL)
Charges
75

Recent inspections

  • 1253435 (VAI Fri Feb 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122884 (NAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091217 (NAI Fri Apr 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012796 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884211 (NAI Fri May 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-4582444-9/11/1 (Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5906125-7/11/1 (Thu May 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9921948-3/11/1 (Thu Mar 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7146402-4/4/1 (Fri Oct 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources