Inconsistent CAPA Lands ALK-Abello a Form 483

May 25, 2012

Corrective and preventive action (CAPA) procedures used to address equipment failures during batch tests at ALK-Abello’s flagship facility are inconsistently applied, an FDA Form 483 states.

Following a mid-November inspection of ALK’s Horsholm, Denmark, plant, investigators found a CAPA had remained open for 10 months following discovery of 44 vials of honey bee allergen extract marked with streaks of product running down their sides, according to the form.

Citing recurrent streaking, employees determined deformation of the filling needle was to blame.

But despite several initial investigations into equipment testing failures, personnel at the plant did not change the frequency of performance checks to ensure reliability, FDA investigators said.

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