Akorn says FDA hit Illinois manufacturing facility with warning letter

Akorn
FDA slaps Akorn with warning letter following an inspection of its sterile injectables plant in Illinois. (Akorn)

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.

Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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, with German generics maker Fresenius Kabi cancelling its nearly $5 billion takeover of Akorn. 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.

Suggested Articles

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.

Eli Lilly is investing $400 million in its Indianapolis site to expand production of insulin and other diabetes meds, and add 100 jobs.

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.