Akorn hit by new FDA warning

26 June 2019

Less than six months after receiving a US Food and Drug Administration (FDA) warning letter about protocol failures at its Illinois manufacturing plant, Akorn (Nasdaq: AKRX) has received another relating to its New Jersey unit.

The agency has written to the US generic drugmaker following a visit to the Somerset site in July and August of 2018, since when the firm claims to have cleaned up its act.

An Akorn statement promised to work with the FDA to resolve the issues in the letter, and expressed full confidence in continuing production at the plant.

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