FDA 483 - EyePoint Pharmaceuticals, Inc. - February 15, 2024

EyePoint Pharmaceuticals, Inc. in Watertown, MA, was inspected by the FDA from February 6-15, 2024, resulting in seven observations, many of which were repeat findings. The inspection revealed significant deficiencies in quality control, manufacturing process validation, aseptic processing, and documentation practices. These issues raise concerns about the consistency, sterility, and overall quality of their YUTIQ 0.18 mg drug product.