FDA WARNING_LETTER - Nomax Inc - October 27, 2016

An FDA inspection of Nomax Inc. in St. Louis, MO, from October 18-27, 2016, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) for its manufactured/repackaged devices, including contact lens cases and Red Cote Disclosing tablets. The firm's devices were deemed adulterated under section 501(h) of the Act. Key deficiencies included the failure to adequately review, evaluate, and investigate device complaints (21 CFR 820.198(c)), and inadequate documentation of corrective and preventive action activities and results (21 CFR 820.100(b)). Management review results and dates were not documented from January 2015 to September 2016 (21 CFR 820.20(c)). The firm also failed to document acceptance activities for a Class II device, FlatPacks (21 CFR 820.80(e)), did not maintain a Device History Record for this product (21 CFR 820.184), and did not evaluate potential suppliers based on specified requirements (21 CFR 820.50(a)(1)). Although Nomax Inc. provided a response, the FDA expressed concerns regarding the timeliness of personnel training, gap analysis for FlatPack products, and a full audit. The letter mandates prompt corrective action, a written response within fifteen business days detailing steps taken, prevention plans, and a timetable for systemic corrections. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on government contracts and device approvals.