Form 483 for Akorn’s Illinois Site Rekindles Questions on Fresenius Buyout

Regulatory NewsRegulatory News | 20 July 2018 |  By 

Back in late February, Fresenius and Akorn traded barbs over whether Akorn breached US Food and Drug Administration (FDA) data integrity requirements that threatened the German drugmaker's $4.3 billion purchase of the US generics maker.

Then in March details on why Fresenius sought to terminate its acquisition of Akorn emerged, with Fresenius alleging a top executive at Akorn had knowingly submitted fabricated data to FDA, and Fresenius pulled out of the deal in April.

And now a Form 483 for Akorn’s manufacturing site in Decatur, IL (the second 483 for the site in less than three years) offers a look inside what FDA found during an inspection in April and May.

The 24-page Form 483 with 13 observations begins with FDA citing the firm for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

The second observation involved Akorn’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas, while the third involved an annual report that did not include a full description of the “manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.”

Elsewhere, FDA found Akorn employees engaged in the manufacture, processing, packing and holding of a drug “lack the training required to perform their assigned functions.”

Akorn did not respond to a request for comment.

Form 483


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