Akorn hit with yet another FDA warning letter

June 25, 2019

Akorn received a warning letter from the U.S. Food and Drug Administration about its New Jersey manufacturing facility, making this the second warning letter this year.

The warning letter is the result of an inspection of the company’s Somerset, New Jersey-based plant in July and August 2018. The letter will likely not impact production but will require the drugmaker to carry out inspections.

In January, Akorn’s Decatur, Illinois manufacturing plant received a warning letter after the drugmaker did not resolve previously highlighted violations. The FDA had also raised concerns about an Akorn manufacturing facility in Amityville, New York.

Read the Reuters report.