FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
Import refusals
/ 799-8771027-1/11/2
799-8771027-1/11/2
Hetero Labs Limited (Unit V) — FEI 3008307735
Recent inspections
1178448
(VAI Fri Aug 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
995278
(OAI Fri Dec 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
928952
(NAI Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
837768
(VAI Fri May 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
700764
(NAI Fri Nov 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (520359)
(Tue Aug 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
AEK-5798514-3/11/1
(Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
AEK-4013386-8/11/1
(Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
147-0170496-8/11/1
(Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
Refusal Details
Date
December 7, 2018
Country
India
Product Category
Drugs and Biologics
Product Code
62VDY24 EFAVIRENZ (ANTI-VIRAL)
Charges
75