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US FDA warns Akorn for again violating manufacturing rules at Illinois facility

Akorn Inc. has received a warning letter from the U.S. Food and Drug Administration for violating manufacturing regulations at its troubled Decatur, Ill., facility.

The U.S. FDA has highlighted numerous issues with Akorn's facility since at least 2017. In one inspection, the agency found that the drugs manufactured at the facility were contaminated because the methods, facilities and controls did not conform to manufacturing guidelines for finished pharmaceuticals. The agency completed a follow-up inspection May 16, 2018.

According to a copy of the warning letter included in a Jan. 9 regulatory document, the agency has determined that the company has failed to adequately respond to the issues raised during the inspections and has not followed procedures designed to prevent microbiological contamination of drug products and ensure sterility. The FDA has directed Akorn to correct the violations.

"Your firm's response is inadequate. We acknowledge you engaged a third party to assist in efforts to re-train personnel and provide additional oversight of aseptic practices, and that you are revising procedures," the FDA said. "However, you did not provide a sufficient evaluation of all batches produced under inadequate conditions. You also did not commit to extensive redesign of your aseptic process operation."

Akorn has 15 working days to submit a response to the warning letter covering all actions taken to correct regulation breaches and prevent them from happening again. The agency has also strongly recommended that Akorn seek assistance from a qualified outside consultant to correct the repeated violations.

In November 2018, the U.S. FDA cited another of the company's plants, a Parsippany, N.J.-based sterile-drug facility, for a litany of quality issues.

The manufacturing facility issues caused Fresenius SE & Co. KGaA to scuttle a planned $4.3 billion acquisition of Akorn in 2018. Akorn had agreed to the acquisition before the quality control concerns were observed by the FDA. Fresenius, after conducting its own investigation, terminated the deal in April 2018.

Akorn filed a complaint against Fresenius for terminating the agreement, which was turned down by the U.S. Delaware Chancery Court in October 2018. An appeal filed with the Supreme Court of Delaware also met the same fate.

Akorn is a generic-drug maker that specializes in sterile injectables, ophthalmics, topical creams, ointments and gels, oral liquids, nasal sprays and respiratory drugs.