FDA 483 - Regeneron Ireland Designated Activity Company - March 14, 2023

During an FDA inspection conducted from March 6-10 and 13-14, 2023, at Regeneron Ireland Designated Activity Company's bulk drug substance manufacturing facility in Limerick, Ireland, an observation was noted regarding the firm's quality assurance practices. The inspection report, known as an FDA Form 483, was issued to Daniel Van Plew, Executive Vice President and General Manager, IOPS. A primary issue identified was that Quality Assurance (QA) reviews do not routinely include the evaluation of source data when reviewing production or Quality Control (QC) data. This indicates a potential gap in the company's data integrity and quality system oversight, which is a critical aspect of Good Manufacturing Practices (GMP). Under the regulatory framework enforced by the FDA, manufacturers are expected to maintain robust quality systems that ensure the reliability and accuracy of all production and quality control records. While the full scope of the inspection's findings is not available in this document due to redactions, this specific observation highlights a need for Regeneron Ireland Designated Activity Company to enhance its QA review procedures. The company is required to investigate this observation, identify its root causes, and implement comprehensive corrective and preventive actions. These actions should ensure that all QA reviews consistently incorporate thorough evaluations of source data to confirm the integrity and compliance of their manufacturing processes and product quality.