FDA EIR - Nomax Inc - October 27, 2016

An FDA inspection of Nomax Inc., a manufacturer of human OTC drugs, prescription drugs, and medical devices located in Saint Louis, MO, was conducted from October 18-27, 2016. The inspection revealed seven significant observations related to Current Good Manufacturing Practices (cGMP) for medical devices. Key violations included the firm's failure to adequately review, evaluate, and investigate quality complaints for Class II devices, with customer service complaint reports not consistently reaching the quality team. Nomax Inc. also failed to properly verify the effectiveness of corrective and preventive actions for out-of-specification products, such as Red Cote Disclosing tablets. Furthermore, the company lacked proper documentation for management review activities, including dates, attendees, and quality trend analyses. Deficiencies were also noted in controlling nonconforming products, documenting acceptance activities with specific numerical values for device specifications, maintaining Device History Records for Class II devices like FlatPacks, and evaluating suppliers for these devices. Nomax Inc.'s management committed to addressing these observations and submitting a written response to the FDA.