FDA Blasts Bristol-Myers Over Puerto Rico Plant

Law360, New York (September 14, 2010, 4:07 PM EDT) -- The U.S. Food and Drug Administration has warned Bristol-Myers Squibb Co. over repeated manufacturing violations at a Puerto Rican facility, saying the pharmaceutical giant could lose government contracts and fail to get its drugs approved if it does not take swift corrective action.

In a letter dated Aug. 30 and publicly released Tuesday, the FDA told the New York-based company that inspectors had found “significant violations” of current good manufacturing practice regulations for pharmaceuticals at a plant in Manati, Puerto Rico.

The agency said that the...
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.