FDA 483 - Mipharm S.p.A. - September 22, 2023

Mipharm S.p.A. in Milano, Italy, was inspected by the FDA, revealing significant deficiencies in their drug manufacturing processes. The inspection found issues with inadequate validation of test methods for drug product release and stability, insufficient process controls, and failures in investigating out-of-specification results. Additionally, the firm lacked secure and complete data backup for laboratory equipment, indicating systemic problems in quality control and data integrity.