FDA 483 - Pharmedica USA, LLC - November 07, 2022

Pharmedica USA, LLC, an OTC drug manufacturer in Phoenix, AZ, was cited for significant deficiencies in its quality control unit and manufacturing processes. The inspection revealed a complete lack of a quality control unit, inadequate procedures to prevent microbiological contamination for sterile products, and a failure to perform essential testing for finished products and components. These issues indicate severe non-compliance with good manufacturing practices, particularly concerning product identity, strength, purity, and quality.