FDA WARNING_LETTER - DMC Medical Ltd - February 22, 2012

An FDA inspection of DMC Medical Ltd. in Clare County, Ireland, from February 20-22, 2012, revealed that the firm, a specification developer for Class I and II medical devices including polycarbonate syringes and cannulas, is not in conformity with current good manufacturing practice requirements. The devices are deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, violating the Quality System regulation (21 CFR Part 820). Key deficiencies identified relate to the firm's design control procedures, specifically failures to adequately establish and maintain procedures for ensuring appropriate design requirements (820.30(c)), defining and documenting design output (820.30(d)), conducting formal documented design reviews (820.30(e)), verifying device design (820.30(f)), validating device design (820.30(g)), and correctly translating device design into production specifications (820.30(h)). DMC Medical Ltd. must notify the FDA within fifteen business days with specific corrective actions, including documentation and a timetable for systemic changes. Failure to correct these violations may lead to federal agencies being advised, non-approval of Class III device premarket applications, and denial of certificates to foreign governments. The FDA emphasized that these issues indicate serious problems within the firm's manufacturing and quality management systems.