FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
Import refusals
/ AEK-7137994-2/31/1
AEK-7137994-2/31/1
Nephron SC, LLC — FEI 3010892830
Recent inspections
1229051
(OAI Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
1167490
(OAI Wed Apr 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1168119
(OAI Wed Apr 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1109980
(VAI Fri Nov 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
1099348
(NAI Fri Jun 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (644180)
(Fri Oct 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (634647)
(Tue Oct 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (610867)
(Tue Sep 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (480214)
(Fri Sep 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter (408461)
(Tue Sep 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
799-6671732-3/11/1
(Mon Jan 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
799-6671732-3/11/2
(Mon Jan 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
Refusal Details
Date
May 19, 2020
Country
United States
Product Category
Drugs and Biologics
Product Code
63BDL02 ALBUTEROL SULFATE (BRONCHODILATOR)
Charges
75