FDA Inspection Flap Prompts Alexion Risk Assessment Reform

Alexion is reviewing its analytical methodologies and procedures to ensure its risk assessments meet the FDA’s expectations, the drugmaker said. Those assurances follow the agency’s rare posting of the drugmaker’s response to a 2012 inspection.

The inspection of Alexion’s Smithfield, R.I., facility resulted in the company receiving a Form 483 in August highlighting concerns about the presence of bacteria in drug batches.

Alexion’s response shows the company defended its risk assessments of two lots of Soliris (eculizumab) that the FDA said shouldn’t be released due to bacteria.

The risk assessments concluded “that the risk to the eculizumab product quality was low,” the response reads. It found that the bacteria present — Bacillus thuringiensis and Acinetobacter radioresistens — were not common human pathogens.

The agency wasn’t satisfied with Alexion’s response, as evidenced by a March warning letter that called the bacteria investigation “inadequate” and identified significant good manufacturing practice violations surrounding several contamination events.

Among them was a corrective action to increase the use of a sporicidal agent in clean rooms. “Your firm failed to verify the effectiveness of your cleaning procedure after the contamination event before further production,” the warning letter reads.

Since receiving the warning letter, Alexion has worked diligently to improve its quality performance and address the FDA’s concerns, including hiring independent experts to review the company’s quality systems and procedures, said spokesman Irving Adler.

Adler emphasized that the warning letter won’t interrupt distribution of Soliris, and that the company plans to add a second contract manufacturing facility by the end of this year.

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