Akorn, a specialty generic pharmaceutical company, reports that it has received a Warning Letter, dated January 4, 2019, from the US Food and Drug Administration (FDA) related to an inspection of its Decatur, Illinois manufacturing facility in April and May of 2018. The company received the Warning Letter for GMP violations for finished pharmaceuticals. Among the issues cited by the FDA were poor aseptic behavior,  non-integral packages containing sterile gloves, packages containing foreign matter, such as fibers, and inadequate cleanroom design and smoke-study deficiencies.

In a January 9, 2019 statement, the company said: “Akorn is committed to the highest standards of quality and compliance, and will continue to work collaboratively with the FDA to resolve all issues addressed in the Warning Letter. The company will respond to the FDA letter within the required 15 working days. The company has full confidence in the quality of the products manufactured at the Decatur facility and expects to continue production at the plant.”

Akorn lost a recent court battle that allowed Fresenius Kabi AG, a specialty and generic pharmaceuticals company, to terminate the companies’ proposed $4.75-billion merger. Fresenius originally agreed to acquire Akorn for $4.3 billion plus approximately $450 million of net debt, for a total of $4.75 billion in April 2017. Fresenius, however, later moved to terminate the company’s merger agreement, asserting that Akorn failed to fulfill several closing conditions. In an October 1, 2018 decision, Delaware Civil Court Vice Chancellor J. Travis Laster declared that Fresenius fulfilled its contractual obligations with Akorn and could legally exit the merger, which Akorn appealed. Fresenius said its decision to terminate the merger was based on, among other factors, material breaches of FDA data-integrity requirements relating to Akorn’s operations found during Fresenius’ independent investigation.

Source: Akorn and FDA