FDA 483 - Annex Medical, Inc. - June 09, 2023

Annex Medical, Inc., a medical device manufacturer, received a Form 483 with three observations highlighting significant deficiencies in their quality system. The inspection revealed inadequate implementation of corrective and preventive action procedures, insufficient controls to prevent product contamination, and poorly defined acceptance activity procedures. These issues indicate a need for improved documentation, justification, and established criteria across several critical processes.