FDA Warns Luitpold Over Drug Manufacturing Violations

Law360, New York (September 13, 2011, 6:59 PM EDT) -- The U.S. Food and Drug Administration revealed Tuesday that it had warned Luitpold Pharmaceuticals Inc. to fix significant manufacturing problems at a plant that temporarily shut down in April after government inspectors uncovered violations.

The FDA said for many years, particulate contamination has been a persistent and serious issue at Luitpold, a branch of Japan-based Daiichi Sankyo Co. Ltd. that manufactures more than 80 injectable drugs.

"Your failure to follow written procedures, complete investigations, adequately scrutinize different defect types, determine root cause, and implement appropriate corrective...
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