Home / Import refusals / B8P-0304813-3/11/1

FDA Import Refusal B8P-0304813-3/11/1 — Mylan Laboratories Limited

Mylan Laboratories Limited — FEI 3010453141

The FDA refused shipment B8P-0304813-3/11/1 from Mylan Laboratories Limited (India) on March 13, 2025. The refused product falls under Drugs and Biologics — LEVOTHYROXINE SODIUM (THYROID HORMONE). Cited charge: 331 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 13, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
66JCA01 LEVOTHYROXINE SODIUM (THYROID HORMONE)
Charges
331

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)
  • 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)
  • 799-3591151-2/11/1 (Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources