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In May 2005, new regulations took effect requiring human tissue firms to properly screen and test donors among other aspects of operations. These also provided for swift action to be taken by FDA in the interest of public health. Applying these new regulations early in 2006, FDA issued to a Ft. Lee, New Jersey, human tissue recovery firm an order to immediately cease all manufacturing operations. The agency monitored the recall of all their tissues to ensure completeness of the operation. So egregious were the deficiencies in the firm’s manufacturing practices, donor screening, record keeping, and other operations that, according to a senior agency official, “allowing the firm to manufacture would present a danger to public health by increasing the risk of communicable disease transmission.”
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