Akorn gets all clear on re-inspection of Decatur, IL plant

Akorn says the FDA had no Form 483 observations during re-inspection of a plant that was cited by the agency in June.

Akorn, which had a sterile manufacturing plant in Decatur, IL, slapped around by FDA inspectors last summer, said the FDA just came back for a reinspection and this time all is well.

The drugmaker announced Monday that  the FDA completed “a re-inspection” of the Decatur plant on Friday and had no Form 483 observations.

“The re-inspection was conducted to verify the implementation and effectiveness of Akorn’s responses to the observations from the June 2016 FDA inspection,” the Lake Forest, IL-based drugmaker said in a statement.    


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The problems the FDA uncovered last summer might have gone unnoticed but the FDA in October posted the Form 483 from the June inspection. The highly redacted report listed half a dozen observations.

Among the problems cited were media fill line issues that plant managers acknowledged should have led to halting production of a commercial batch. Instead Akorn said it allowed production to proceed. Additionally, there was poor oversight of some media fill operations. The FDA also nicked the drugmaker for not finding the root cause of problems that led to foreign matter and cracked vials in a sublot of the antibiotic clindamycin.  

The June inspection followed a number of recalls by Akorn and its Hi-Tech Pharmacal unit.  In March, Actavis began voluntarily recalling 24 lots, amounting to 447,150 bottles, of ciprofloxacin ophthalmic solution that were manufactured by Hi-Tech. The solution failed impurities and degradation specs for an unknown impurity. Before that, Hi-Tech recalled 57,920 bottles of sulfacetamide sodium ophthalmic solution that failed antimicrobial effectiveness testing.


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