A New Jersey-based company that makes tissue-based products used in open-heart surgeries is embroiled in a heated court battle and war of words with the Food and Drug Administration (FDA). This tension between Shelhigh and the FDA began April 17 when the federal regulatory agency pulled about 1 million parts at the company’s plant in New Jersey after a 10-week inspection of the facility in the fall of 2006.
According to the civil complaint that the FDA filed in the U.S. District Court in Newark, the company violated several federal safety manufacturing standards. FDA officials say that the manufactured products were placed in a poorly constructed and maintained clean room, that Shelhigh did not properly inspect the products for possible microbial contamination, that they did not follow procedures to test products for sterility and that the company was not able to scientifically support their product expiration dates.
These products include pediatric heart valves, conduits for blood flow, surgical patches, arterial grafts and annuloplasty rings for repairing heart valves. FDA officials said that since these devices were placed in seriously ill patients their sterility is absolutely vital to prevent infection in those patients. An FDA press release states that Shelhigh’s own records […]

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