FDA 483 - Liberty Medical Solutions, LLC - June 04, 2026

Liberty Medical Solutions, LLC, a repacker/relabeler in Tampa, FL, was cited for a complete lack of a functional quality management system during an FDA inspection. The firm failed to establish criteria and methods for effective process control, lacked essential resources and information, and did not implement actions to achieve planned results or monitor processes. This includes fundamental deficiencies such as not tracking complaints, inadequate CAPA, and no documented procedures for training, internal audits, or supplier controls.