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Sunday, February 05, 2006"FDA's investigation of BTS revealed serious and widespread deficiencies in their manufacturing practices that provide the agency reason to believe that allowing the firm to manufacture would present a danger to public health by increasing the risk of communicable disease transmission," FDA official Margaret Glavin said in a statement. In a letter to the company published on the FDA's Web site, the agency cited death certificates provided by BTS that changed the age and cause of death of at least eight donors when compared to their official death certificates. The company has not operated since October when the FDA announced it was under investigation, an FDA spokesman said. Published reports said the company sold bones from the late broadcaster Alistair Cooke, who died in March 2004, before he was cremated. His death at age 95 from cancer would have made his tissues off-limits for transplant. posted by Sydney on 2/05/2006 11:09:00 AM 0 comments 0 Comments: |
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