FDA WARNING_LETTER - Hubei Weikang Protective Products Co., Ltd. - June 04, 2015

An FDA inspection of Hubei Weikang Protective Product Co. Ltd. (HWPPC) in Xiantao City, Hubei, China, from June 1-4, 2015, revealed that the firm's manufactured devices, including surgical suits and nursing pads, are adulterated under section 501(h) of the Act. This is due to non-conformity with the Quality System regulation (21 CFR Part 820). A previous warning letter was issued in 2013 for similar violations. The firm's response to the FDA 483 was deemed inadequate. Specific violations include the failure to establish and maintain procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a), with inadequate documentation of internal CAPA audits. Additionally, the firm failed to establish and maintain procedures to ensure purchased products and services conform to specified requirements, per 21 CFR 820.50, lacking documentation for component supplier qualification and material source changes. Consequently, HWPPC's devices are subject to refusal of admission into the U.S. (detention without physical examination). The firm must respond within fifteen business days with documented corrective actions, a prevention plan, and a timetable for systemic improvements to address these serious manufacturing and quality management system deficiencies.