FDA 483 - Cerovene Inc. - April 28, 2025

Cerovene Inc., a contract manufacturer in Valley Cottage, NY, received a Form FDA 483 with three observations during an inspection from April 21-28, 2025. The observations detail deficiencies in equipment cleaning and maintenance, inadequate written production and process controls, and insufficient controls over computer systems. These issues indicate potential risks to drug product quality and integrity.