FDA 483 - Cerovene Inc. - April 28, 2025

An FDA inspection of Cerovene Inc., a contract drug manufacturer in Valley Cottage, NY, revealed significant deficiencies in equipment cleaning and maintenance, production and process controls, and computer system controls. Observations included caked residue on "clean" equipment, inadequate cleaning procedures lacking defined parameters, and unvalidated hand cleaning processes. Additionally, the firm failed to review data, audit trails, and alarm reports from critical equipment, and allowed shared "admin" logins, indicating a risk to drug product quality and integrity.