FDA 483 - Opti Source International - April 04, 2024

Opti Source International, an OTC drug manufacturer in Bellport, NY, was cited with 11 observations during an FDA inspection. The firm failed to adhere to numerous Current Good Manufacturing Practices, including using expired components, lacking a quality control unit, and failing to perform essential product and component testing. These deficiencies indicate a systemic breakdown in quality assurance for their Optimal Foaming Hand Sanitizer product.