The Allston, Massachusetts-based manufacturing plant of Genzyme Corp. will be re-inspected by the Food and Drug Administration (FDA), in order to ensure whether the manufacturing issues that the agency discovered at the facility in February have been addressed.

The re-inspection decision by FDA follows the results of the May inspection of the plant, which had revealed that the problems that the agency had warned the company about in February had not been satisfactorily rectified.

FDA's February letter pointed to certain paucities at the plant - specifically those pertaining to maintenance of equipment; computerized systems; production controls; and the inadequate implementation of procedures for prevention of microbiological contamination.

In fact, the plant had to be temporarily closed in June, after the detection of a virus in one of six bioreactors used in the development of the company's best-seller drugs - Cerezyme and Fabrazyme, which are enzyme replacements for rare genetic disorders.

With Genzyme now claiming that all the related issues have already be rectified, and that FDA's re-inspection should not cause any further delay its recently-communicated timelines for the plant, Genzyme officials expect resumption of production this month and release of products by November or December.

The persistent issues at the mentioned manufacturing facility have become a reason for Genzyme to cut its earnings forecast for 2009, and have virtually become a 'hang over' for the investors!