FDA 483 - Freelance Formulations LLC - February 08, 2023

An FDA inspection of Freelance Formulations LLC in Bartow, FL, a drug manufacturer, revealed significant deficiencies in its quality control unit, manufacturing processes, and material controls. The firm failed to adequately approve and reject materials, validate critical manufacturing and cleaning processes, control environmental conditions, and perform identity testing on incoming components. These issues indicate a lack of robust quality systems essential for ensuring the quality and safety of its OTC drug products.