Arrow International sterilization software validation deficient, FDA tells company.
This article was originally published in The Gray Sheet
Executive Summary
ARROW INTERNATIONAL STERILIZATION SOFTWARE VALIDATION DEFICIENCIES are detailed by FDA in a warning letter to the firm released the week of Aug. 25. The FDA correspondence specifically cites the catheter manufacturer's Asheboro, North Carolina facility for failure "to appropriately validate the software" for "computer controlled sterilizers" as required by FDA's good manufacturing practices regulations.