FDA 483 - Tianish Laboratories Private Limited - November 28, 2025

An FDA inspection of Matrix Pharmacorp Private Limited in Patancheru, India, an API manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate cleaning procedures, unvalidated equipment, a deficient water monitoring system, and a quality unit failing to conduct thorough investigations. The findings indicate a broad lack of control over critical manufacturing processes and quality assurance.