FDA 483 - KDL Precision Molding - February 07, 2019

An FDA inspection of RDI Precision Molding in Pacoima, CA, a Class II & III medical device manufacturer, identified two significant observations. The firm failed to review, evaluate, and revalidate a process when changes occurred, specifically regarding the use of an unvalidated liquid injection molding machine for FemCap devices. Additionally, the company lacked established procedures to control labeling activities for its FemCap and (b)(4) devices, leading to undocumented labeling inspections and missing primary identification labels in Device History Records.