Healex Products Inc. – FDA Warning Letter, Jul 2, 2010

An FDA inspection of Healex Products Inc. in Providence, Rhode Island, conducted in June and July 2010, revealed significant violations regarding the manufacture of their dental cements and desensitizing agents (Preserve Plus, Preserve Temp, Desens-Ionomer). These products are classified as medical devices. The inspection determined that the devices are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act (the Act) because manufacturing methods, facilities, or controls do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Additionally, the devices are misbranded under section 502(o) of the Act. Key violations include the firm's failure to establish and maintain procedures for: ensuring purchased products and services conform to requirements (21 CFR 820.50(b)); controlling device design (21 CFR 820.30(a)(1)); receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)); and establishing overall QS procedures and instructions (21 CFR 820.20(e)). The firm also failed to register its facility and list its devices with the FDA, constituting misbranding. Healex Products Inc. must promptly correct these violations and provide a written response within fifteen working days detailing specific corrective actions, preventive measures, and a timetable. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.