FDA 483 - Naari Pharma Private Limited - November 01, 2025

Naari Pharma Private Limited, an Indian manufacturer of finished drug products, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including an inadequate quality control unit, poor environmental monitoring and risk assessment for cross-contamination, facility design flaws leading to contamination, and insufficient investigations into environmental excursions and analytical discrepancies. These findings indicate a lack of robust quality systems and controls over manufacturing processes and laboratory operations.