EyePoint Pharmaceuticals, Inc. – FDA Warning Letter, Feb 15, 2024

The FDA issued a Warning Letter to EyePoint Pharmaceuticals, Inc. following an inspection from February 6-15, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for their combination drug product, YUTIQ. The drug product is deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate unexplained discrepancies, identify root causes, implement appropriate preventative actions, and conduct timely investigations. Examples include an uninvestigated atypical release rate for YUTIQ batch 2022-00008 (linked to product complaints), lack of long-term preventative actions for roof leaks, and delayed investigation for YUTIQ batch 2023-00008's failed release rate. The firm's response was inadequate, lacking scientific justification for proposed specifications and commitment to investigate all affected batches. 2. **Inadequate Production and Process Controls (21 CFR 211.100(a) and 211.100(b)):** Lack of adequate scientific procedures to assure drug product identity, strength, quality, and purity. Deficiencies included insufficient process performance studies for blend uniformity, operation of manufacturing machines at lower-than-required air pressures, failure to generate statistical process