- Generic drug manufacturer Akorn on Thursday disclosed receipt from the Food and Drug Administration of a Form 483 inspection form detailing four sets of issues at the company's Amityville, New York plant.
- An FDA investigator found deficiencies in aseptic processing areas, while also noting a lack of records to demonstrate maintenance and sanitization of certain equipment, failure to follow a written stability testing program and improper testing of dropper tips used for two ophthalmic solutions.
- The inspector also noted the company had received at least 134 complaints for spray/dropper malfunctions over a period of four years through January 2019. Most of those complaints were identified in an Akorn investigation.
Akorn now has the chance to try to remedy the problems and avert a possible FDA warning letter or regulatory action targeting the plant. The company is already dealing with issues flagged by the FDA at other facilities, including numerous violations at its Decatur, Illinois operation detailed in a January warning letter.
The company disclosed the latest inspection report along with fourth-quarter financial results that showed a widening net loss and an 18% drop in revenue. Shares in the company fell by more than 2% in early Thursday trading.
Fourth quarter earnings reflected "the many challenges that have impacted our business of late, including increased competition for many of our generic and promoted products, supply issues, and regulatory and legal challenges," Akorn CEO Douglas Boothe said in a statement.
Akorn said it's working on "rebuilding shareholder value" after German drugmaker Fresenius Kabi last year terminated a $4.3 billion agreement to buy Akorn for $34 a share. At the time, Fresenius cited "material breaches" by Akorn of FDA data integrity requirements.
The FDA raised that concern again in its warning letter about the Decatur facility. Analysts at Raymond James in January cautioned that the FDA seemed to be questioning "key foundational aspects" of Akorn's quality programs and might be more stringent in future inspections of other plants.