DMC Medical Technology & Manufacturing Co., Ltd. – FDA Warning Letter, Apr 25, 2012

On September 12, 2012, the FDA issued a Warning Letter to DMC Medical Technology & Manufacturing Co., Ltd. following an inspection from April 23-25, 2012, in Heyuan City, China. The inspection found that the firm's polycarbonate syringes, connectors, and vein irrigation cannula were adulterated under section 501(h) of the Act, as manufacturing methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. Failure to verify or validate corrective and preventive actions (CAPA) for effectiveness (21 CFR 820.100(a)(4)). 2. Inadequate documentation of CAPA activities (21 CFR 820.100(b)). 3. Failure to review and revalidate processes after changes or deviations (21 CFR 820.75(c)). 4. Inadequate procedures for controlling nonconforming product, including accepting critical defects without justification (21 CFR 820.90(a)). 5. Failure to establish and maintain acceptance procedures for in-process product, leading to release of nonconforming syringes (21 CFR 820.80(c)). 6. Failure to adequately control environmental conditions, including lack of microbiological monitoring, unaddressed