The US Food and Drug Administration (FDA) has not given its approval to Genzyme Corp.'s new drug for treating Pompe's disease, a rare muscle disorder, until and unless the drug manufacturing firm addresses production deficiencies at its Allston Landing plant in Boston.

The FDA ruling comes after it made an announcement last week about having found foreign particles like fragments of stainless steel, including bits of non-latex rubber in vials of several Genzyme products, including Cerezyme, its best selling Gaucher disease treatment.

According to Genzyme executives Monday, the section of its Allston plant responsible for handling vial filling and finishing had been temporarily shut down, while the company fixed the problem of its antiquated machinery shedding metal fragments.

Genzyme said additional internal controls in the fill / finish area were being established, including the transfer of additional filling activities to contract manufacturers, while using its Waterford, Ireland facility to excess capacity.

While, this will not delay shipments of Cerezyme, shipments of Fabrazyme, its treatment for Fabry disease may be impacted briefly

Both rare genetic disorders, Gaucher and Fabry can lead to life-threatening organ damage.