FDA WARNING_LETTER - Accurate Set Inc. - November 13, 2009

An FDA inspection of Accurate Set Inc. in Newark, NJ, from October 30 to November 13, 2009, revealed significant violations concerning their medical devices, including Setacure and various acrylic products. The firm's devices were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Specific QS deficiencies included failures in establishing and maintaining procedures for corrective and preventive action (21 CFR § 820.100(a)), inadequate complaint handling and investigation records (21 CFR § 820.198(c), (d), (e)), lack of procedures for evaluating and documenting nonconforming product investigations (21 CFR § 820.90(a)), failure to maintain device history records (21 CFR § 820.184), and insufficient quality audits (21 CFR § 820.22). Additionally, Setacure and Heat and Self Cure Tooth Shade Acrylic Powder devices were found adulterated under section 501(f)(1)(B) for lacking premarket approval (PMA) or an investigational device exemption (IDE), and misbranded under section 502(o) for failure to submit a 510(k) premarket notification. The FDA requires prompt corrective action within fifteen working days, including documentation and a timetable. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, PMA approvals, and Certificates to Foreign Governments.