Why the FDA Is Coming Down on Akorn

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Akorn Inc. (NASDAQ: AKRX) shares dipped on Wednesday after the company received a warning letter from the U.S. Food and Drug Administration (FDA). The letter is in relation to an inspection of its Decatur, Illinois, manufacturing facility back in April and May of 2018.

In a release, the company said that it would respond to the FDA letter within the required 15 working days. Akorn also noted that it is committed to the highest standards of quality and compliance, and it will continue to work collaboratively with the FDA to resolve all issues addressed in the warning letter.

Ultimately, the letter listed violations in regards to the agency’s current good manufacturing practice regulations, including poor aseptic behavior, as well as environmental and personnel monitoring.

According to the letter, Akorn also failed to follow “appropriate written procedures” in order to prevent microbiological contamination of the drugs being produced at the plant.

This is not the first time that Akron has been under the gun in recent memory. Just this fall, a Delaware judge ruled that German health care group Fresenius could walk away from its $4.75 billion deal to acquire Akorn and rejected Akorn’s claim that the merger agreement had been breached.

The deal originated late in April 2017, when Fresenius offered to buy Akorn for $34 per share, in an all-cash transaction. Currently, shares are only at a fraction of that price.

This company just can’t seem to catch a break.

Shares of Akorn were last seen down about 6% at $3.69, in a 52-week range of $3.14 to $33.63. The stock has a consensus analyst price target of $8.00.

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