FDA 483 - EyePoint Pharmaceuticals, Inc. - August 28, 2019

EyePoint Pharmaceuticals, Inc. in Watertown, MA, was cited for significant deficiencies across its manufacturing operations, particularly concerning quality control, investigations, and aseptic processing. The inspection revealed failures in investigating product complaints, out-of-specification results, and environmental monitoring excursions, alongside issues with data integrity in computer systems and inadequate maintenance of cleanroom conditions. The firm also demonstrated poor control over stability studies, equipment calibration, cleaning procedures, and supplier qualification for critical components.