Akorn says the FDA has slapped the company with a warning letter following an inspection last year of its sterile injectables plant in Decatur, Illinois.
According to a filing (PDF) with the Securities and Exchange Commission, the letter issued by the regulatory agency was dated Jan. 4 and was related to an inspection of the plant in April and May of last year. Akorn said in a release it would work with the FDA “to resolve all issues addressed in the warning letter.”
In the filing, the Lake Forest, Illinois-based company said it was cited for poor aseptic behavior and that it failed to follow all appropriate written procedures to prevent microbiological contamination of the products produced at the facility.
Additionally, inspectors found foreign fibers and other contaminants on gloves that were said to be sterile. The agency also said the company’s response to its Form 483 issued following the inspection was inadequate.
The facility has been under FDA scrutiny for some time. In 2016, the plant was given a Form 483 that cited it for a number of issues, including problems in the media line that plant managers acknowledged should have led to a halt in production of a commercial batch. Instead, workers allowed it to proceed. It was also cited for some media fills not being overseen by quality-control personnel, and much of the work wasn’t logged. The FDA gave Akorn the all-clear for those issues in 2017.
Akorn had a tumultuous year in 2018, having to abandon its plans of a $4 billion takeover of German generics maker Fresenius. Then in November, Akorn’s Parsippany, New Jersey, plant was hit with a 22-page Form 483. The plant, which makes sterile drugs, including eye products, lotions and jellies, was cited for nearly a dozen issues, some of which could lead to contamination, the FDA said.
To top the year off, Raj Rai, Akorn’s chief executive, announced in December that he would retire.