FDA Warns J&J Unit Over Faulty Sterilization Tools

Law360, New York (May 25, 2010, 7:42 PM EDT) -- The U.S. Food and Drug Administration has put a Johnson & Johnson subsidiary on notice that it has failed to address and fix defects with some of its sterilization and cleaning tools.

The agency published a warning letter Tuesday that it had sent to Advanced Sterilization Products on March 12 following an FDA inspection of the Irvine, Calif.-based facility between June and September. The company is a part of J&J unit Ethicon Inc.

The letter noted several complaints by consumers over the company’s Sterrad and other...
To view the full article, register now.