Home / Import refusals / AEK-2620661-3/11/1

FDA Import Refusal AEK-2620661-3/11/1 — Mylan Laboratories Limited

Mylan Laboratories Limited — FEI 3010453141

The FDA refused shipment AEK-2620661-3/11/1 from Mylan Laboratories Limited (India) on January 17, 2023. The refused product falls under Drugs and Biologics — DOLUTEGRAVIR SODIUM (ANTI-VIRAL). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 17, 2023
Country
India
Product Category
Drugs and Biologics
Product Code
62VDY73 DOLUTEGRAVIR SODIUM (ANTI-VIRAL)
Charges
75

Recent inspections

  • 1095599 (NAI Fri May 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 960871 (VAI Fri Feb 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870220 (VAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-9307357-3/10003/1 (Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-9867116-1/11/1 (Tue Apr 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • B8P-0304813-3/11/1 (Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8160423-1/21/1 (Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5060456-2/11/1 (Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources