An FDA inspection of a Cardinal Health facility in Dublin, OH that distributes point-of-use sharps containers has determined that the facility does not have adequate management controls as part of an effective quality system. The inspection found that a number of a quality system procedures have not been established, according to a May 28 warning letter. Among the procedures lacking are written corrective and preventive action procedures, design change control procedures, complaint procedures, and medical device reporting procedures. Additionally, FDA's letter says a management representative has not been appointed to ensure that the quality system requirements are met, and management reviews do not ensure that the quality system satisfies the requirements of CFR part 820. The letter also cites the firm for failing to conduct quality audits and failing to have a procedure for acceptance and rejection of incoming product. --James G. Dickinson