US FDA issues Akorn with Form 483 for Decatur plant

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Food and drug administration

US FDA inspectors have raised concerns about Akorn Inc’s manufacturing facility on Grand Avenue in Decatur, Illinois in a Form 483 made public this month.

The Form 483​ details three observations flagged by US Food and Drug Administration (FDA) investigator Brian Nicholson, who visited the site in April.

The issues relate to quality control, manufacturing equipment and procedures designed to prevent microbial contamination that are used in vial filling activities at the site.

Publication of the document comes less than a year after Akorn announced​ it had addressed problems flagged in a Form 483​ issued by the US FDA after an inspection in June 2016.

Akorn did not respond to a request for comment about the latest Form 483.

Fresenius Kabi is due to acquire Akorn for $4.3bn in a transaction expected to close before the end of the year.

A spokesman for the German firm told us "We are well aware of this issue [the Form 483​]"

He added that "Both companies fit very well together. As soon as the deal has been closed, we will start working with our new colleagues on further developing the joint businesse​s."

Akorn operates a second manufacturing facility on Wyckles Road in Decatur. The Form 483 does not relate to this facility.


The original article incorrectly stated that Fresenius Kabi's acquisition of Akorn will complete early next year.

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