FDA 483 - Exactech Sarasota, Inc. - July 25, 2025

Exactech Sarasota, Inc. received a Form FDA 483 following an inspection, citing significant deficiencies across its quality system. The firm failed to adequately establish and follow procedures for process controls, corrective and preventive actions, nonconforming product handling, environmental controls, supplier quality management, training, and acceptance activities. These issues indicate a systemic breakdown in ensuring device conformance to specifications and maintaining a state of control.