FDA 483 - Evonik Corporation - January 10, 2020

Evernik Corporation Birmingham Laboratories, a sterile drug manufacturer in Birmingham, AL, was inspected by the FDA from January 6-10, 2020. The inspection revealed significant deficiencies across multiple areas, including equipment design, laboratory controls, data integrity, contamination prevention, and inadequate written procedures for production and process controls. Additionally, the firm failed to ensure sufficient GMP training for employees, indicating a broad lack of adherence to current good manufacturing practices.