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EyePoint Pharmaceuticals failed to maintain Current Good Manufacturing Practice (CGMP) standards for its drug manufacturing operations, rendering its drug products adulterated. During a February 2024 inspection, investigators identified significant violations including the company's failure to thoroughly investigate unexplained discrepancies and failures in batch specifications, such as an atypical high release rate value for YUTIQ (fluocinolone acetonide intravitreal implant) that was not properly investigated for root cause or preventative actions. The company did not conduct timely investigations to ensure other potentially affected batches were identified, creating systemic compliance deficiencies in their quality control and batch investigation procedures.