FDA 483 - Regeneron Ireland Designated Activity Company

Regeneron Ireland Designated Activity Company, a Bulk Drug Substance Manufacturer in Limerick, Ireland, was cited for significant deficiencies in its quality unit's control of documents and records, data integrity practices, and investigation procedures. The inspection revealed issues with the retention of original GMP forms, inadequate manual integration processes, incomplete electronic data review, and insufficient investigation of deviations and HEPA filter failures. These observations indicate a systemic lack of robust quality oversight and data management.