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Regulatory Focus™ > News Articles > 2019 > 7 > FDA Warns Akorn for Repeat Violations

FDA Warns Akorn for Repeat Violations

Posted 09 July 2019 | By Zachary Brennan 

FDA Warns Akorn for Repeat Violations

Following a more than one-month inspection last summer, the US Food and Drug Administration (FDA) on Tuesday released a warning letter for Akorn’s Somerset, New Jersey manufacturing facility due to cGMP violations.

The warning letter, issued 13 June and discussed by Akorn on 25 June, echoes some of the observations made by FDA in a Form 483 for the site last November.

FDA specifically raises concerns with the site’s quality system, which “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

Akorn’s data integrity issues led to the collapse of the merger agreement between Akorn and Fresenius Kabi.

The warning letter also notes how Akorn’s investigation into product defects from one lot of its ketorolac tromethamine ophthalmic solution was inadequate and “did not include a meaningful evaluation” of potential processing line root causes.

“Many of your investigations, including those initiated for stability failures, remained open for long periods of time, up to 19 months, without adequate justification. Unresolved drug product quality problems may pose a risk to patients,” FDA says.

FDA also notes a previous warning letter sent to another Akorn site in Illinois last January for inadequate controls for manufacturing sterile drugs, among other violations.

“These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate. Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance,” FDA says.

Warning Letter


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