21. Also of concern to shareholders was a recent warning letter American Bio Medica received from the FDA. 22. But federal regulators issued three warning letters to Schering-Plough that year, detailing widespread problems in factories in New Jersey, Puerto Rico and Ireland. 23. Company officials have learned from the warning letter experience, Oram said, and will likely be disposed toward more prompt disclosure. 24. CryoLife Inc., received a warning letter from the Food and Drug Administration that said the company did not adequately investigate complaints about one of its surgical products. 25. DePuy Inc. received a warning letter from the U.S. Food and Drug Administration after informing the agency it had mistakenly placed an unacceptable advertisement in a U.S. medical journal. 26. Disetronic Holding AG said in response to a U.S. Food and Drug Administration warning letter that its patients should not be concerned about the safety of its products. 27. Doctors have a hard time keeping up with all the new medicines on the market, and with FDA warning letters about their risks. 28. ESC Medical Systems Ltd. said it will change the way it describes its skin laser after receiving a warning letter from the Food and Drug Administration. 29. Essentially, the thinking goes, a warning letter from Olympic officials will have a limited effect. 30. FDA officials say that warning letters tend to lead the agency to give a company greater scrutiny during subsequent inspections. |
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