Akorn gets FDA warning letter for Illinois plant 2 MIN READ
(Reuters) - Akorn Inc said on Wednesday it received a warning letter from the U.S. Food and Drug Administration following an inspection of the company’s Decatur, Illinois manufacturing plant last year.
The warning letter comes after an inspection of the facility by the regulator in April and May.
Shares of the company, which failed to salvage its takeover deal with Germany’s Fresenius SE & Co KGaA, fell 8.6 percent to $3.60 before the bell.
Lake Forest, Illinois-based Akorn said it would respond to the FDA letter within 15 working days and expects to continue production at the plant.
The letter, dated Friday, lists violations related to the regulator’s current good manufacturing practice regulations, which include poor aseptic behavior. The FDA also pointed out violations of environmental and personnel monitoring.
Akorn also failed to follow “appropriate written procedures” to prevent microbiological contamination of the drugs being produced at the plant.
In April, Fresenius abandoned its plan to acquire the generic drugmaker, citing misconduct in reporting drug development data to U.S. healthcare regulator.
Akorn said in December its Chief Executive Officer Raj Rai would retire, after the Delaware Supreme Court upheld a lower court’s decision to allow Fresenius to walk away from its over $4 billion acquisition.
JANUARY 9, 2019https://www.reuters.com/