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Cambrex says it has received a warning letter from FDA connected with a March 2009 inspection of the company’s generic active pharmaceutical ingredient manufacturing (API) facility in Milan, Italy. The custom manufacturing firm says the issues raised relate primarily to the collection and maintenance of lab data. Cambrex says it has already addressed some of the problems and is working to resolve the rest. Failure to act would mean FDA could withhold any product approvals listing the facility as the API source or prevent entry into the U.S. of products manufactured at the site.
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