FDA 483 - Signature Formulations, LLC - September 30, 2021

Signature Formulations, LLC in Phoenix, AZ, was inspected and found to have severe deficiencies across its laboratory, quality, and production systems. The firm failed to ensure drug product quality through inadequate testing, lack of specifications, and a non-existent quality control unit. Repeated observations highlight a systemic failure to adhere to basic manufacturing and quality control principles.