Home / Import refusals / AEK-8833896-4/11/1

FDA Import Refusal AEK-8833896-4/11/1 — Access Bio, Inc.

Access Bio, Inc. — FEI 3008474767

The FDA refused shipment AEK-8833896-4/11/1 from Access Bio, Inc. (United States) on March 8, 2021. The refused product falls under Devices — REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID. Cited charge: 508

Refusal Details

Date
March 8, 2021
Country
United States
Product Category
Devices
Product Code
83QJR REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
Charges
508

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 (NAI Tue May 25 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

FDA data resources