10/17/2012 7:50:41 AM
Last April, the FDA inspected Celltex Therapeutics, which has ties to a controversial stem cell company in South Korea called RNL BIO, after a University of Minnesota bioethics professor wrote the agency to over concerns about patient safety, quality of scientific research supporting the proposed business model and whether both conform to federal and state laws and regulations. At the time, the agency issued a 483 inspection listing dozens of violations (see here). Now, the FDA has sent a warning letter, citing Celltex for developing a product that is an unlicensed biologic and for violating numerous good manufacturing practices, including a failure to establish and follow written procedures designed to prevent microbiological contamination. The list of problems is, in fact, quite long and also mentions a failure to validate cell culture processes and conduct sterility investigations, as well as a failure to create a quality-control unit to approve or reject components and containers, among other things. There was also a failure to establish a written record of major equipment cleaning, maintenance and use.
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