FDA Warns Pfizer Italian Unit Over Contamination

Law360, New York (April 9, 2013, 3:19 PM EDT) -- The U.S. Food and Drug Administration on Tuesday released a warning letter accusing an Italian unit of Pfizer Inc. of potentially failing to prevent bacterial contamination of a diluting agent for kidney cancer drug Torisel and threatening to block imports until problems are corrected.

The March 27 letter, sent to Pfizer subsidiary Wyeth Lederle SpA, said inspections at a Catania, Italy, manufacturing site turned up “significant violations of current good manufacturing practice regulations for finished pharmaceuticals.”

According to the letter, Wyeth shipped a portion of a...
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.