FDA 483 - Sanofi S.r.l. - May 22, 2023

An FDA inspection conducted between May 12 and May 22, 2023, identified significant deficiencies at a pharmaceutical manufacturing facility, whose name is not specified in the provided document. The FDA Form 483 report highlighted critical violations related to sterile drug product manufacturing and aseptic processing simulations. The primary issue involved inadequate procedures to prevent microbiological contamination. Specific observations included non-aseptic setup of sterilized equipment, operators compromising sterility by touching sterile surfaces with non-sterile gloves, blocking "first air" during critical operations, and improper handling of rejected vials that were transferred with acceptable products without a formal cross-contamination risk assessment. Furthermore, the facility's aseptic process simulations, essential for validating sterile manufacturing, were found to be unrepresentative of actual drug product manufacturing. The simulations used dedicated equipment rather than the actual production lines, failing to accurately assess routine sterility risks. These observations necessitate immediate corrective actions to ensure compliance with regulatory standards for sterile drug manufacturing, requiring revised aseptic processing procedures and representative simulations to safeguard product quality and patient safety.