FDA WARNING_LETTER - Copious International, Inc. - May 17, 2012

An FDA inspection of Copious International, Inc. in Heyuan, China (May 14-17, 2012), revealed significant violations regarding its medical devices, including surgeon caps, gowns, and nurse hats. The devices were deemed misbranded under section 502(t)(2) of the Act, due to the firm's failure to furnish required information under section 519 and 21 CFR 803 (Medical Device Reporting). Key deficiencies included the failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17). The firm also failed to establish and maintain adequate procedures for corrective and preventive action (CAPA) under 21 CFR 820.100(a), with its CAPA procedure lacking critical elements like identifying actions for recurrence prevention and verification of effectiveness. Furthermore, the firm lacked adequate procedures for receiving, reviewing, and evaluating complaints, specifically regarding the determination of MDR reportable events, as required by 21 CFR 820.198(a)(3). The firm's June 1, 2012, response was deemed inadequate, lacking evidence of implemented procedures, systemic corrective actions, historical record reviews, and employee training. Copious International, Inc. must respond within fifteen business days, detailing specific corrective actions, prevention plans, and a timetable for completion, including documentation. The FDA emphasized that these violations indicate serious systemic problems, potentially impacting federal contracts.