International Isotopes Inc. – FDA Warning Letter, Jul 22, 2011

On October 26, 2011, the FDA issued a Warning Letter to International Isotopes, Inc. following a July 18-22, 2011 inspection of their Idaho Falls facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 210 and 211) for their radiopharmaceutical, Sodium Iodide I-131 solution, rendering the drug adulterated. Key CGMP deficiencies included failure to conduct specific identity tests for components and validate supplier analyses [21 CFR § 211.84(d)(2)], inadequate calibration of instruments [21 CFR § 211.160(b)(4)], lack of appropriate controls over computer systems for data accuracy [21 CFR § 211.68(b)], absence of detailed written procedures for component handling and approval [21 CFR § 211.80(a)], failure to establish procedures for labeling reconciliation [21 CFR § 211.125(c)], and insufficient procedures for examining packaging and labeling materials before operations [21 CFR § 211.130(d)]. Additionally, the firm was cited for marketing Sodium Iodide I-131 solution as an unapproved new drug, violating section 505(a) of the Act [21 U.S.C. § 355(a)], as no FDA-approved application was in effect. The firm's initial August 3, 2011, response to the FDA-483 was deemed insufficient, lacking detailed corrective actions and evidence of completion. While the drug is unapproved, FDA will allow continued manufacturing pending CGMP correction to avoid undue patient burden, consistent with their "Marketed Unapproved Drugs - Compliance Policy Guide." International Isotopes must promptly correct all violations and respond within fifteen working days, detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including injunction, and impact future contracts or approvals.