FDA 483 - Cerovene Inc. - March 23, 2026

From March 16 to March 23, 2026, the FDA conducted an inspection of Cerovene Inc., a contract drug manufacturer located in Valley Cottage, NY. The inspection resulted in several significant observations regarding the facility"s failure to maintain appropriate quality and safety standards, many of which were noted as repeat violations from previous inspections. A primary issue involved inadequate cleaning procedures; investigators discovered white residue and powder buildup on non-dedicated equipment, such as capsule machines and tablet presses, that had been officially marked as clean. Additionally, manufacturing tools were found stored improperly on the floor, increasing contamination risks. The FDA also identified critical failures in computer and data security. The firm used shared login credentials for production machinery, failed to monitor audit trails, and did not protect laboratory equipment from unauthorized changes to system dates and times. These practices compromise the integrity of the firm"s manufacturing records. Furthermore, the laboratory was found using expired and undated chemical standards for testing drug products. These findings were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While the report does not represent a final agency determination, Cerovene Inc. is required to conduct internal audits and provide a formal response to the FDA detailing their corrective actions to address these deficiencies.