Daiichi Sankyo, Inc. Unit Warned by FDA Over Manufacturing
Published: Sep 14, 2011
The Food and Drug Administration warned Luitpold Pharmaceuticals Inc. regarding "significant" and repeated manufacturing violations at a New York plant. The agency issued the company, which is a unit of the Japanese pharmaceutical firm Daiichi Sankyo Co. Ltd. (4568.TO), a warning letter on Aug. 31. The letter was made public Tuesday. The FDA cited Luitpold for failures to resolve problems with particulate contamination in some of the company's injectable drugs, which the agency deemed "a persistent and serious issue at your firm." The FDA said failures to fully investigate particulates and product failures "are repeat violations" found in annual inspections since 2008.