FDA 483 - Maiva Pharma Private Limited - October 29, 2022

An FDA inspection of Maiva Pharma Private Limited, a sterile drug manufacturer in Hosur, India, revealed significant deficiencies across its operations. The firm was cited for severe issues with data integrity and computer system controls, inadequate environmental monitoring in aseptic processing areas, and insufficient validation of cleaning, disinfection, and aseptic processes. Additionally, the firm failed to properly document personnel performing critical manufacturing steps and exhibited poor airflow control and visualization studies.