Home / Compliance actions / 568173

FDA Warning Letter — Akorn Operating Company LLC

Case 568173 — FEI 2246848

The FDA took a Warning Letter action against Akorn Operating Company LLC on June 13, 2019 (Somerset, NJ). The action was issued by CDER and concerns drugs products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Akorn Operating Company LLC
Date
June 13, 2019
Fiscal Year
2019
Product Type
Drugs
Center
CDER
Location
Somerset, NJ (United States)

Facility

Recent inspections

  • 1169676 (OAI Tue May 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012024 (NAI Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976869 (NAI Mon Apr 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929221 (VAI Fri Jun 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884894 (VAI Thu May 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources