Contamination at Another Genzyme Manufacturing Plant
On February 12, Genzyme (Cambridge, MA) notified Cerezyme users of an impurity found in a vial manufactured at its Waterford, Ireland plant.
On February 12, Genzyme (Cambridge, MA) notified Cerezyme users of an impurity found in a vial manufactured at its Waterford, Ireland plant.
The impurity was found during a routine quality check in December. Subsequent testing by Genzyme confirmed that the source of the contamination was tubing used during fill–finish. The tubing has since been replaced.
According to the release by Genzyme, the impurity may have been present at very low levels in a very small percentage of Cerezyme vials (less than 1%), it has not been associated with any adverse effects in humans, and any risk from the impurity is remote. Therefore, the Cerezyme batch in question has been released for use. The company stated that the overall safety profile of Cerezyme remains unchanged.
The announcement by Genzyme comes at a time when Genzyme is still recovering from a series of manufacturing problems at its US manufacturing sites. It took a major blow last year after a virus was discovered at its Allston Landing, MA plant, forcing it to shut down production for six weeks. This shut down in production caused production of Cerezyme to move to the Waterford plant.
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