Root Cause Analysis and FDA WL

Your firm failed to conduct adequate manufacturing investigations into out-of-specification (OOS) results obtained by your external laboratory for your (...), an over-the-counter (OTC) drug product. As such, root cause(s) for the OOS results were not determined and no corrective and preventive actions (CAPA) were identified."

"your cursory investigation lacked appropriate CAPA"

"As a manufacturer, you have a responsibility to fully investigate OOS results and process deviations that may impact product quality."

"the procedures for handling deviations and complaints are inadequate. For example, the deviations procedure lacks details for the investigation process".

FDA WL