FDA 483 - Terumo BCT Sterilization Services, Inc. - October 14, 2015

Terumo BCT Sterilization Services, Inc. in Lakewood, CO, a contract sterilizer, received a Form FDA 483 with two observations. The inspection revealed that the firm had not adequately validated software used in production and lacked documented evaluations for a software engineering services supplier. These findings indicate deficiencies in the firm's quality system regarding software and supplier management.