FDA 483 - Terumo BCT, Inc. - August 25, 2017

An FDA inspection of Terumo BCT, Inc. in Lakewood, CO, a medical device manufacturer, revealed multiple quality system deficiencies. Observations included inadequate procedures for environmental control, process validation documentation, complaint handling, and control of nonconforming products. Additionally, issues were noted with corrective and preventive action effectiveness verification and the maintenance of device master records.