The heavily redacted Form 483 relates to an inspection of Akorn’s sterile manufacturing facility at 1222 W. Grand Avenue, Decatur, Illinois, in April and May this year.
Regulators noted 13 observations, including a lack of written procedures designed to prevent microbiological contamination of drug products intended to be sterile.
According to the US Food and Drug Administration (FDA), poor aseptic processing techniques were observed via videotape, as well as during a walk-through inspection: “Operators were seen reaching over open vials during interventions. These vials were not removed from the line.”
The Agency continued: “Operators were seen touching their gowning. In one case, the operator touched their lower leg/shoe, then proceeded to touch a stopper bag…Fallen vials were not removed and instead replaced onto the line.”
The FDA also flagged inadequate cleaning and disinfecting systems and stated that, “Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.”
Akorn did not respond to a request for comment.
The Form 483 marks the third for Akorn in the last two years. In October 2016, the US regulator published a Form 483 for Akorn’s Decatur site, which was re-inspected and cleared two months later. In October 2017, the FDA published a Form 483 following an April inspection at the same plant.
In April 2017, we reported German injectable drug specialist Fresenius Kabi was in talks to buy Akorn. However, one year later Fresenius announced it had terminated the merger agreement, alleging that Akorn had failed to fulfil several closing conditions: “Fresenius’ decision is based on, among other factors, material breaches of FDA data integrity requirements related to Akorn’s operations found during Fresenius’ independent investigation.”