FDA 483 - Freelance Formulations LLC - February 08, 2023

Freelance Formulations LLC, a drug manufacturer in Bartow, FL, was cited for significant deficiencies in its quality control unit, manufacturing process validation, and material control. The firm failed to adequately approve and reject materials, validate critical processes like mixing and cleaning, and ensure proper environmental conditions, leading to the use of contaminated water in an OTC drug product. Additionally, the company relied solely on supplier certificates of analysis without performing identity testing or validating supplier reliability.