FDA 483 - Signature Formulations, LLC - November 22, 2023

Signature Formulations, LLC, a drug manufacturer in Phoenix, AZ, was cited for severe and repeat violations related to its quality control unit and manufacturing processes. The inspection revealed a lack of fundamental procedures for production controls, product testing, stability programs, and complaint handling. These systemic failures indicate a critical lack of control over drug product identity, strength, purity, and quality.