FDA 483 - Roche Diabetes Care, Inc. - July 25, 2019

Roche Diabetes Care, Inc. in Indianapolis, IN, was issued a Form FDA 483 following an inspection from July 15-25, 2019, citing three observations. The firm failed to adequately validate a process related to a debris detection system and did not maintain complete supporting data or updated specifications. Significant deficiencies were also noted in corrective and preventive action (CAPA) procedures, including lack of effectiveness verification and numerous overdue tasks. Additionally, process control procedures for cleaning and preventive maintenance were not adequately established.