US FDA hits Akorn with second Form 483 this year

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Bmcent1)
(Image: Getty/Bmcent1)

Related tags: Akorn, Form 483, Fda

Akorn’s Somerset facility becomes it second to require remediation action, following the issuance of a US Form 483.

The US Food and Drug Administration (FDA) carried out its inspection in Somerset, New Jersey, between July 23 and August 30 of this year.

In total, 11 observations were noted in the Form 483​, which included the findings that batches of Akorn’s ophthalmic solution, that had failed stability testing, had entered the US market. In addition, levels of impurity were recalculated after the original notation, according to the agency.

Another observation reads: “Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.”

In response to the FDA’s action, a spokesperson for the company told us: “Akorn takes FDA compliance issues very seriously, and is focused on working collaboratively with the FDA as Akorn continues to improve its practices and procedures to ensure compliance with FDA regulations.”

Dealing with two sites

The most recent Form 483 means that Akorn faces the task of rectifying issues at its Somerset plant as well as in Decatur, Illinois, site – which was issued a Form 483 earlier this year​.

The company addressed the issues facing both plants in its third quarter financials.

“Our Decatur facility received a Form 483 at the conclusion of an FDA inspection in May 2018, to which we submitted a robust response in early June. We have made substantial progress (approximately 80% of our action items are complete) and we are on track to complete the majority of the remaining action items by the end of 2018,”​ the company stated.

In regards to its Somerset facility, the company noted, “We are on schedule with our action items and have made good progress already with approximately 45% of our action items completed.”

The two Form 483s have not been without financial consequence for the company, which revealed that it had incurred expenses of $23.7m (€20m) on data integrity assessment and remediation efforts.

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