Akorn hit with warning letter from FDA

Jan 09, 2019

The FDA has followed up a Form 483 to Akron Inc. with a warning letter. 

According to the company, the FDA sent the warning letter on Friday, listing several violations, such as poor aseptic behavior and personnel monitoring at its Decator, Ill. plant.

Akorn, a specialty generics company, received two Form 483 notices last year — one in May and then another in November. Among the violations found during FDA inspections last year was the presence of contaminants, such as foreign fibers, on operator gloves. 

The FDA stated that the company’s response to the most recent Form 483 was inadequate. The agency is now asking the company to produce a detailed plan about how it will resolve the violations. 

Akorn said it plans to continue production at the plant and will follow up with the agency within 15 working days. 

Read the full Reuters report.

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