The Food and Drug Administration (FDA) has issued a warning letter to International Isotopes, Inc., indicating that an inspection revealed “significant violations of Current Good Manufacturing Practices (CGMP) for finished pharmaceuticals.” The violations involve the company’s Sodium Iodide I-131 solution, an oral medication used to treat hyperthyroidism and some thyroid cancers, and consist of alleged failure to (i) validate a supplier’s analyses, (ii) calibrate instruments and other equipment, (iii) exercise appropriate controls over computer systems to assure data accuracy, (iv) maintain written procedures for handling components and drug product containers and closures, and (v) maintain written procedures pertaining to product labeling.
While FDA also claimed that the company is manufacturing the radiopharmaceutical without an application and is thus marketing an unapproved drug, the agency said it would “allow you to continue manufacturing this product pending correction of your CGMP violations. This decision is consistent with FDA’s commitment to take action against marketed unapproved drugs without imposing an undue burden on patients.” FDA further stated that if the company takes any action in response to the letter “that will result in a decreased number of finished drug products,” the company should notify the Center for Drug Evaluation and Research’s Drug Shortages Program immediately “to ensure that your action(s) does not adversely affect the public health.”
According to a news source, International Isotopes President and CEO Steve Laflin indicated that the company has corrected most of the violations. He was quoted as saying, “[we take] our responsibility to consistently supply quality products to our customers very seriously and [are] taking this opportunity to improve our manufacturing processes in complete accordance with current good manufacturing processes.” FDA sought a response within 15 working days of receipt of the October 26, 2011, letter, and warned that failure to act could result in legal action. See Law360, November 10, 2011.