FDA 483 - Maiva Pharma Private Limited - July 22, 2025

Maiva Pharma Private Limited in Hosur, India, was cited with five observations during an FDA inspection from July 14-22, 2025, primarily concerning significant deficiencies in quality control, aseptic processing validation, and personnel training. Key issues include inadequate investigation of product defects, compromised data integrity in the Empower system, insufficient aseptic process simulation, unqualified visual inspection personnel, and deficient airflow studies for sterile filling lines. These findings indicate a moderate to severe level of non-compliance with cGMP regulations for sterile drug manufacturing.