FDA 483 - Ensemble Orthopedics, Inc. - August 04, 2023

Ensemble Orthopedics, Inc. in West Lake Hills, TX, was inspected from August 1-4, 2023, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning corrective and preventive actions, complaint handling, supplier qualification, and quality audit procedures. These issues indicate a lack of adequate control over critical manufacturing processes and record-keeping.