FDA EIR - Nomax Inc - February 01, 2018

During an FDA inspection conducted from January 23 to February 1, 2018, Nomax Inc., a manufacturer of human prescription drugs and Class I, II medical devices in Saint Louis, MO, underwent a compliance follow-up and routine drug manufacturing inspection. This inspection was conducted under FDA Compliance Programs 7356.002 (Human Drug Manufacturing) and 7382.845 (Medical Device Manufacturers). The inspection followed a Warning Letter issued on December 15, 2016, for significant deficiencies observed during a prior inspection in late 2016, which included issues with quality complaint investigations, corrective and preventive actions (CAPA), management review documentation, nonconforming product handling, device history records, and supplier evaluation for medical devices. The current inspection confirmed that corrections to these previously cited issues were satisfactorily implemented. However, the 2018 inspection identified new concerns, resulting in a two-item FDA 483, Inspectional Observations, for inadequate cleaning of production equipment and an inadequate retain program. Additionally, several verbal objections were communicated, highlighting further critical issues. These included the failure to perform assay testing for each flavor of Effer-K® Potassium Bicarbonate tablets during stability studies, the absence of impurity testing or a risk assessment for Effer-K® tablets, and the lack of qualification for equipment used to verify lot codes and expiration dates. Other deficiencies involved insufficient timeframes in Annual Product Review procedures and a failure to perform growth promotion testing for microbiological media. Nomax Inc. is required to address these deficiencies to ensure full compliance with the Food, Drug and Cosmetic Act.