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Import refusals
/ 799-8969517-1/11/1
799-8969517-1/11/1
Mylan Laboratories Limited — FEI 3005587313
Recent inspections
1117137
(NAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
1076887
(NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
1050962
(VAI Thu Apr 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
986244
(OAI Wed Sep 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
920472
(VAI Wed Mar 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (517906)
(Fri Mar 31 2017 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)
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)
Refusal Details
Date
February 1, 2017
Country
India
Product Category
Drugs and Biologics
Product Code
62VCA15 TENOFOVIR DISOPROXIL FUMERATE
Charges
75