FDA 483 - Naari Pharma Private Limited - June 07, 2022

An FDA inspection of Naari Pharma Pvt. Ltd. in Rudrapur, India, revealed significant deficiencies in manufacturing practices. Observations included inadequate cleaning processes leading to residue on equipment, severe lack of controls over electronic data and audit trails, and failure to qualify critical packaging leak test apparatus. These issues indicate a concerning lack of control over drug product quality and data integrity.