On 13 June 2019, Akorn Inc was issued with a FDA Warning Letter following an inspection of their Somerset New Jersey facility in July-Aug 2018. 4 lengthy citations conclude with general comments on the inadequacy of Akorn’s Quality Systems Guidance, Data Integration Remediation recommendations and a reminder of their responsibility to correct deficiencies found during quality assurance program audits.
This may not come as a surprise, when its recent history is reviewed; Akorn was named in 26 Enforcement Reports and is responsible for 32 reported Drug Shortages in the US since the beginning of 2017. It was also cited in an FDA Import Alert for inadequate GMP compliance at its Indian subsidiary, Akorn PVT.
Despite the pending lawsuit for its failed takeover of Akorn, Fresenius may yet conclude that it got off lightly.
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Published: July 30 2019
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