FDA 483 - Shine & Pretty USA Corporation - July 23, 2025

Shine & Pretty USA Corporation in Camarillo, CA, was cited for significant deficiencies in its manufacturing processes and quality control during an FDA inspection. Observations included inadequate process validation, unreliable component testing, insufficient equipment cleaning procedures, and a failure to follow quality control unit responsibilities, including facility maintenance and record-keeping. These issues indicate a lack of robust controls to ensure the identity, strength, purity, and quality of their OTC drug products.