The FDA warned Ion Labs in a letter about violations of current good manufacturing practices (cGMPs) that include the failure to establish test procedures or other laboratory control mechanisms to ensure drug purity and to put in place written procedures for production and process controls.rnThe agency conducted an inspection from Nov. 24, 2008, to Dec. 31, 2008, according to the warning letter dated July 31 and posted recently on the FDA's website. The agency acknowledged receiving the company's Feb. 9 responses to the latest Form 483 observations but called the responses inadequate.
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