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Pharmaceuticals / Regulatory Affairs

Akorn Receives Second Warning Letter This Year

July 19, 2019

The FDA hit Illinois-based generic drugmaker Akorn with an extensive warning letter for violations at its Somerset, New Jersey facility — the company’s second warning of the year.

The agency inspected the plant from July 23 to Aug. 30, 2018 and noted violations similar to those previously noted in an April 2018 inspection of the company’s Decatur, Illinois facility.

The FDA cited the facility for incomplete investigations of out-of-specification results and manufacturing deviations, saying they lacked scientifically-supported conclusions and prompt corrective action and preventive actions.

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