FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
Import refusals
/ AEK-8833896-4/11/1
AEK-8833896-4/11/1
Access Bio, Inc. — FEI 3008474767
Recent inspections
993227
(NAI Tue Sep 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
734128
(NAI Mon Aug 29 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
675952
(OAI Tue Aug 31 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
664896
(OAI Tue May 25 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (121589)
(Wed Dec 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
Refusal Details
Date
March 8, 2021
Country
United States
Product Category
Devices
Product Code
83QJR REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
Charges
508