FDA 483 - Matrix Pharmacorp Private Limited - September 01, 2025

An FDA inspection of MATRIX PHARMACORP PRIVATE LIMITED, UNIT 10, an API manufacturer in Anakapalli Dist., India, revealed significant deficiencies. The firm failed to adequately validate analytical methods, lacked sufficient controls over computerized systems leading to data integrity concerns, and had unscientific sampling procedures for API release testing. These issues indicate a systemic breakdown in quality control and data management practices.