FDA 483 - Medical Solutions, Inc. - July 11, 2025

Medical Solutions, Inc. in Chantilly, VA, a specification developer and initial importer, received a Form FDA-483 citing significant deficiencies in its quality system. The firm failed to adequately establish and implement procedures for both corrective and preventive actions (CAPA) and management review. These observations indicate a lack of control over critical quality processes and timely completion of required actions.