FDA 483 - Luster Products Inc - September 13, 2024

Luster Products Inc, an OTC drug and cosmetic manufacturer in Chicago, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including a lack of a comprehensive stability testing program for hand sanitizers, inadequate laboratory controls for release testing, and failure to perform identity testing on critical components. Additionally, the quality control unit's responsibilities were not fully documented or followed, and employees lacked essential CGMP training.