MDS to end commercial bioanalytical operations in Montreal facility

By Elaine Rigoli

Tampa, Fla., March 31 - MDS, Inc. will voluntarily wind down all commercial bioanalytical liquid chromatography and mass spectrometry operations in its Montreal facility, according to a news release.

The company provided the update of its retrospective review of bioanalytical studies conducted in its Montreal facility from 2000 through 2004 after a recent audit by the Food and Drug Administration identified a number of issues pertaining to the effectiveness and management of the five-year review.

MDS said it is working diligently to meet all FDA expectations and is committed to resolving all outstanding issues in a timely manner.

In order to enhance this effort, MDS is bringing in experienced project management from outside the MDS Pharma Services division in addition to winding down the commercial operations in Montreal.

This will allow for complete focus to accelerate the activities related to this review, the company said.

Commercial activities will continue in MDS Pharma Service's other bioanalytical sites in Lincoln, Neb.; Blainville, Quebec; Zurich, Switzerland; and Sittingbourne, United Kingdom.

"I am disappointed that we have not made progress at the rate necessary on this review. We are enhancing the leadership and project management of this effort in order to complete this review to the FDA's satisfaction. Finalizing this effort in a high-quality way is the top priority for the company," Stephen P. DeFalco, president and chief executive officer, said in a statement.

MDS is a life sciences company based in Toronto.

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