Regeneron Ireland Designated Activity Company – FDA 483, May 7, 2021

Regeneron Ireland Unlimited Company, a drug substance manufacturer in Limerick, Ireland, was cited for significant deficiencies across multiple areas. These include inadequate engineering controls for electronic data integrity, insufficient personnel training and procedural detail in manufacturing, recurring microbial ingress risks from in-process leaks, and ineffective investigations and corrective actions for HEPA filter failures. The findings indicate systemic issues requiring comprehensive remediation.