FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
Import refusals
/ B8P-0304813-3/11/1
B8P-0304813-3/11/1
Mylan Laboratories Limited — FEI 3010453141
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
Warning Letter (690897)
(Thu Dec 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
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)
Refusal Details
Date
March 13, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
66JCA01 LEVOTHYROXINE SODIUM (THYROID HORMONE)
Charges
331