FDA warns AlloSource over failure to follow anti-infection procedures.The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has issued a report charging that AlloSource, Inc., an Englewood, CO-based tissue processing company failed to follow its own anti-infection rules and may have shipped some contaminated contaminated, v 1. made radioactive by the addition of small quantities of radioactive material. 2. made contaminated by adding infective or radiographic materials. 3. an infective surface or object. tissue to hospitals, according to the Associated Press. AlloSource received a warning letter from the FDA in July saying it had violated its own policies for handling cadaver cadaver /ca·dav·er/ (kah-dav´er) a dead body; generally applied to a human body preserved for anatomical study.cadav´ericcadav´erous ca·dav·er n. skeletal and muscular tissue. Thomas Cycyota, AlloSource president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , acknowledged the company had violated its own procedures and has subsequently invested $1 million to improve its testing procedures. The FDA concluded that AlloSource distributed bone tissue from a cadaver that had tested positive for the bacteria Clostridium perfringens Clostridium per·frin·gens or Clostridium welchii n. Gas bacillus. Clostridium perfringens Infectious disease An anaerobic gram-positive spore-forming rod, widely distributed in nature and present in the , the AP reported. However, none of the 5 patients receiving the tainted tissue developed infections. AlloSource provides tissue transplants to bout 85,000 patients a year in Colorado, Missouri, Southern California, Illinois and Wyoming. "We appreciate the scrutiny they've given us, and we believe we're probably 45 to 60 days away from significantly being done with these issues," Cycyota said. |
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