FDA 483 - Signature Formulations, LLC - July 29, 2025

An FDA inspection of Signature Formulations, LLC in Phoenix, AZ, a drug manufacturer, revealed significant and repeat deficiencies across multiple systems. The firm was cited for inadequate equipment cleaning, poor contamination control for hazardous APIs, lack of proper product testing and stability studies, and unvalidated manufacturing processes and water systems. These findings indicate a serious lack of adherence to Good Manufacturing Practices, posing risks to drug product quality and safety.