FDA 483 - Rakshit Drugs Private Limited - November 22, 2024

An FDA inspection of Rakshit Drugs Private Limited in Anakapalli, India, an API and intermediate manufacturer, revealed significant deficiencies in quality control. Observations included inadequate equipment cleaning procedures, insufficient equipment qualification, flawed out-of-specification investigations, and unsecured computerized system data backups. Additionally, improper microbiological water quality analysis was noted, indicating systemic issues in ensuring product quality and data integrity.