Genzyme Says FDA Inspectors Will Oversee Plant

Law360, New York (March 25, 2010, 4:28 PM EDT) -- Based on concerns over manufacturing practices at one of Genzyme Corp.'s Massachusetts plants, the U.S. Food and Drug Administration has announced plans to put inspectors at the facility to make sure drugs produced there are safe.

The FDA told Genzyme on Tuesday that it would take enforcement action to ensure that the company's Allston, Mass., plant complies with federal good manufacturing practice regulations.

The move will probably lead to a consent decree calling for a third party to oversee operations at the plant for an extended...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.