FDA 483 - Evonik Active Oxygens, LLC - November 06, 2024

An FDA inspection of Evonik Active Oxygens, LLC, an API manufacturer in Pasadena, TX, revealed significant deficiencies in computerized system controls and quality system procedures. The firm failed to secure laboratory computer access and did not adequately document or investigate deviations, conduct mock recalls, or implement corrective actions for identified non-conformances. These issues indicate a lack of robust controls over data integrity and quality management.