Akorn plant cited in FDA Form 483

Akorn ($AKRX) has faced a variety of manufacturing problems that have led to recalls. It turns out, it is also dealing with a Form 483 issued recently for one of its plants in Decatur, IL.

The highly redacted report, posted this week on the FDA website, shows that a June inspection at a plant on Grand Avenue led to 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 but which they said was allowed to proceed. On top of that, some media fills were not overseen by quality-control personnel and much of the work was not logged.


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Inspectors also pointed out that both foreign matter and cracked vials were found in a sublot of the antibiotic clindamycin, but the plant never got to the root cause of the issues and failed to see if other sublots were similarly affected.

The inspectors also questioned the plant’s rationale for its sampling procedures as well as raising concerns about environmental monitoring.

This comes on top of the recalls that Akorn and its Hi-Tech Pharmacal unit have been wrestling with. 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.

Related Articles: 
Akorn's Hi-Tech is the source of large Actavis recall 
Akorn and Hi-Tech recall more than 900 gallons of dental rinse 
Akorn's Hi-Tech source of another recall


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