Akorn U.S. sterile plant passes FDA reinspection

An Akorn sterile injectables drug facility that was cited in a Form 483 by the FDA has since been cleared.

Akorn has gotten the all-clear from the FDA for its sterile manufacturing site in Decatur, Illinois, that was cited in a Form 483 last year.

The Lake Forest, Illinois-based company in its earnings report Wednesday said that the FDA had given the facility a NAI status (No Action Indicated), the highest status level available, following a December 2016 reinspection.  

The FDA in June cited the facility for a number of issues. Among the problems observed were media fill line issues that plant managers acknowledged should have led to halting production of a commercial batch. Instead workers allowed it to proceed. Additionally some media fills were not overseen by quality-control personnel and much of the work was not logged.

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Inspectors also pointed out that both foreign matter and cracked vials were found in a sublot of the antibiotic clindamycin, but the plant never determined the root cause of the issues and failed to see if other sublots were similarly affected.

The announcement that the FDA is now satisfied with the Akorn facility came in an earnings report in which CEO Raj Rai reported the company had exceeded $1 billion in annual revenues for the first time, with revenues up 13.4%.

The company also reported that besides the Decatur plant, its other three FDA approved manufacturing sites are in good standing following 2016 FDA inspections.

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