FDA Discovers Slew Of Quality Issues At Amylin Plant

Law360, New York (March 15, 2010, 6:08 PM EDT) -- A U.S. Food and Drug Administration inspection of the Amylin Pharmaceuticals Inc. factory responsible for manufacturing certain formulations of its blockbuster diabetes drug Byetta has revealed a number of quality control issues.

In an inspection report posted Thursday on the FDA Web site, the agency found that Amylin’s West Chester, Ohio, plant did not follow procedures to prevent microbiological contamination of drug products and that many employees were not adequately trained for their job positions, among other issues.

The FDA also found that established laboratory control...
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