By Saumya Joseph
(Reuters) – Generic drugmaker Akorn Inc said on Thursday the U.S. Food and Drug Administration had raised concerns about its manufacturing plant in Amityville, New York, that included a lack of records on the maintenance and cleaning of equipment.
The FDA’s issuance of the notice following an inspection of the plant, through a so-called Form 483, is the latest in a series of setbacks for Akorn and comes a month after the agency issued a warning letter related to another plant.
The agency, following an inspection of the plant, also observed deficiencies in the facility’s systems for keeping its equipment free from contamination, the FDA said in the form dated Feb. 13.
The FDA said it found that containers in the plant were not tested for conformance with written procedures, and highlighted the more than 50 customer complaints, over the last year, related to malfunctions in the spray or dropper of Akorn’s products.
None of the observations were identified as repeat observations, a company spokeswoman said in an emailed statement.
On finding issues upon inspection of company facilities, the agency issues a Form 483, which if not resolved can lead to a “warning letter” and in worst case, a ban.
The Amityville plant is the third Akorn facility since 2018 to get a Form 483.
Akorn’s manufacturing plant in Decatur, Illinois, received a warning letter last month after it did not resolve previously highlighted violations such as failure to follow procedures to prevent contamination of drugs produced at the plant.
On a post-earnings conference call on Thursday, Chief Executive Officer Douglas Boothe called the FDA’s observations at the Amityville plant “minor”.
“I recognize the frustrations felt by our many stakeholders and there is a lot of work to be done to return our company to a path of profitable growth.”
Boothe, who took charge last month, expects the majority of the company’s remediation and improvement activities to be in place by the middle of the year.
Akorn has faced a number of challenges over the past year, including termination of its more than $4 billion buyout deal by Germany’s Fresenius SE & Co KGaA in April.
Shares of the Lake Forest, Illinois-based company fell nearly 3.15 percent to $3.69 in trading around noon.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta and Shailesh Kuber)