FDA EIR - AccessClosure, Inc., A Cardinal Health Company - February 01, 2016

An FDA Quality System Inspection was conducted at AccessClosure, Inc., A Cardinal Health Company, a manufacturer of Class III vascular closure devices in Santa Clara, CA, from January 21 to February 1, 2016. This inspection, performed as a post-market follow-up to PMA P040044 and in response to an anonymous complaint, found that the company had successfully addressed all observations from a prior 2014 inspection. These previous issues involved failures in reporting medical device events, validating manufacturing processes, and monitoring production, with the firm subsequently granted Alternate Summary Reporting for its vascular hemostasis devices. While no formal FDA-483 observations were issued during the 2016 inspection, minor issues were discussed with management. These included the need to enhance general employee training on complaint handling, ensuring all staff can effectively collect necessary information. The FDA also highlighted the absence of specific qualification requirements for personnel performing visual inspections, a crucial aspect for product quality. Furthermore, the company was advised to improve its process for obtaining comprehensive information from complainants, extending beyond a minimum number of attempts, particularly for events potentially requiring Medical Device Reporting. AccessClosure

’s management committed to reviewing and implementing voluntary procedural changes to address these areas.