Kinetic Unit Warned Over Breast Implant Marketing

Law360, New York (May 12, 2011, 6:55 PM EDT) -- The U.S. Food and Drug Administration cautioned a Kinetic Concepts Inc. subsidiary last week over its failure to properly respond to an inspection of the company's promotion of breast implant products and sponsorship of clinical studies, according to a regulatory filing Thursday.

The FDA told LifeCell Corp. on May 5 it was unsatisfied with LifeCell's initial response to the results of an inspection the agency carried out in November, Kinetic Concepts said in an 8-K filing with the U.S. Securities and Exchange Commission. The FDA "observed noncompliance with FDA regulations covering the promotion of...
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