FDA 483 - Matrix Pharmacorp Private Limited - September 05, 2025

An FDA inspection of MATRIX PHARMACORP PRIVATE LIMITED, UNIT 10, an Active Pharmaceutical Ingredient (API) manufacturer in Andhra Pradesh, India, was conducted from September 1-5, 2025, resulting in a Form FDA 483. The report, issued to Associate Vice President Venkata Atchuta Rama Raju Mudunuri, detailed significant observations indicating non-compliance with Good Manufacturing Practices.

The main issues identified were a failure to adequately validate and verify analytical methods, with discrepancies found between validation reports and Drug Master File submissions regarding impurity detection/quantitation limits and acceptance criteria. Furthermore, the firm lacked sufficient controls over computerized systems, particularly for HPLC data. Initial chromatograms were often missing, and multiple user roles had the capability to modify critical data, compromising data integrity for products distributed to the US market. Lastly, the company's API sampling procedures lacked scientific justification, failing to ensure representative samples and comprehensive batch quality assessment for numerous products released since 2018.

These observations highlight critical deficiencies in the firm's quality systems. MATRIX PHARMACORP is required to address these findings by implementing comprehensive corrective and preventive actions to ensure the integrity, quality, and compliance of their pharmaceutical products.