FDA 483 - Spinal Balance, Inc. - October 29, 2021

An FDA inspection of Spinal Balance, Inc. in Swanton, OH, a medical device manufacturer, resulted in a Form 483 with three observations. The firm was cited for significant deficiencies in its quality system, specifically regarding inadequate procedures for complaint handling, corrective and preventive actions (CAPA), and the monitoring and control of validated sterilization processes. These issues indicate a failure to adequately establish and follow critical quality system procedures.