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

An FDA inspection of EyePoint Pharmaceuticals, Inc., a human sterile drug manufacturer located in Watertown, MA, was conducted from February 6-15, 2024. This inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified significant deviations from current Good Manufacturing Practices (GMP). The agency issued a Form FDA 483 detailing seven observations, several of which were repeat findings from a previous 2021 inspection. Key issues centered on the firm's quality system and manufacturing controls for its YUTIQ 0.18 mg drug product. Specifically, the company failed to thoroughly investigate unexplained discrepancies, particularly concerning atypical drug release rates for YUTIQ, leading to the distribution of a lot associated with adverse events and therapeutic failures. Investigations for environmental monitoring excursions and recurrent facility issues, such as roof leaks and temperature fluctuations, were inadequate. Process control deficiencies were noted, including the absence of a continued process verification program and flawed visual inspection procedures lacking action levels and required investigations for product defects. The firm also did not adhere to its own Out of Trend procedures. Deviations from written production procedures were observed, such as the use of unapproved cleaning materials and incorrect equipment settings. Furthermore, equipment was not adequately cleaned or maintained, with evidence of rust and unknown residues, and a lack of cleaning validation for product-contact surfaces. Aseptic processing areas exhibited critical deficiencies, including unvalidated cleaning processes with incorrect disinfectant contact times, and operators failing to follow established gowning and personnel conduct procedures, increasing microbiological contamination risks. Finally, the firm demonstrated poor documentation practices, with inadequate control over critical CGMP records. EyePoint Pharmaceuticals, Inc. is required to address these observations by implementing comprehensive corrective and preventative actions to ensure compliance with regulatory standards and the quality and safety of its sterile drug products.