Akorn site hit with 11 observations by FDA

Akorn has sufferedafurther manufacturing setback after the US Food and Drug Administration (FDA) issued the US firm’s local manufacturing facility in Somerset, New Jersey, with a 22-page ‘Form 483’ inspection report highlighting 11 observations.

Akorn has sufferedafurther manufacturing setback after the US Food and Drug Administration (FDA) issued the US firm’s local manufacturing facility in Somerset, New Jersey, with a 22-page ‘Form 483’ inspection report highlighting 11 observations.

An audit that took place from 23 July to 30 August found that batches of azelastine 0.05% ophthalmic solution had...

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