Akorn Receives FDA Warning Letter

By Emily Forster -

June 27, 2019

Akorn, a specialty generic pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) related to an inspection by the FDA of its Somerset, New Jersey manufacturing facility conducted in July and August 2018.

Akorn says it will continue to work collaboratively with the FDA to resolve all issues addressed in the Warning Letter. The company says it will respond to the FDA within the required 15 working days from receipt of the letter.

Akorn says that the company launched a company-wide action plan earlier this year to improve the timing and effectiveness of its operations, quality systems, and compliance-enhancement initiatives with an emphasis on transparency and quality.

The company says it expects to continue production at the Somerset, New Jersey plant.

Source: Akorn