Sanofi Vaccines US Inc. – FDA EIR, Apr 22, 2023

An FDA surveillance inspection of Sanofi Pasteur Inc. in Swiftwater, PA, was conducted from March 20 to April 22, 2023, with a pause between March 24 and April 18. The inspection focused on the company's production of Praluent (alirocumab), a CDER-regulated biologic drug product, under the regulatory framework of Current Good Manufacturing Practices (CGMP) and Compliance Program 7356.002A for Sterile Drug Process Inspections. The site is registered as a contract manufacturer for human biologic drug products and various vaccines, subject to 21 CFR 210/211.

The inspection identified three main observations, detailed in a Form FDA 483. First, equipment design deficiencies were noted, specifically an operational "dead leg" in the Praluent drug product flow path, which could impact product quality. Second, inadequate cleaning and sanitization practices were observed, as operators failed to properly sanitize contacted surfaces during operations. Third, deficiencies in aseptic processing areas were cited, particularly regarding air supply and aseptic technique. This included operators handling sterile filling needles with gloved hands, which potentially compromised sterility by interrupting high-efficiency particulate air (HEPA) filter airflow over the critical zone.

In response to these findings, Sanofi Pasteur Inc.'s management committed to providing a written response to the FDA within 15 business days, outlining their corrective actions to address the identified issues. The inspection also followed up on previous findings, verifying that relevant corrective actions for Praluent production from a 2018 inspection had been implemented.