Aztex Enterprises Ltd. – FDA Warning Letter, Jun 13, 2017

The FDA inspected Aztex Enterprises Ltd. in Burlington, Ontario, Canada, from June 12-13, 2017, and found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, Aztex's drug products are deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The firm's July 12, 2017, response was inadequate, lacking detail and sufficient supplier evaluations. Key violations include the failure to establish an adequate quality control unit with proper authority (21 CFR 211.22(a)), absence of written procedures for labeling operations and complaint handling for OTC drugs, and a lack of written procedures for supplier qualification. Furthermore, Aztex used adulterated materials from a supplier on FDA Import Alert 66-40, rendering their own manufactured drugs adulterated. The FDA strongly recommends engaging a qualified CGMP consultant. As a result of these deficiencies, Aztex was placed on Import Alert 66-40 on October 19, 2017. Until all violations are corrected and compliance is confirmed, FDA may withhold approval of new applications and continue to refuse admission of Aztex's articles into the United States. The firm must respond in writing within 15 working days detailing corrective actions and recurrence prevention.