FDA 483 - Finecure Pharmaceuticals Limited - November 22, 2024

An FDA inspection conducted from November 18 to November 22, 2024, at Finecure Pharmaceuticals Limited, Unit I in Ahmedabad, Gujarat, India, resulted in the issuance of a Form FDA 483. The inspection identified a critical observation concerning the company's written stability program for drug products. Specifically, the firm was found to be utilizing a test method for the assay of stability samples that is not considered stability-indicating. Furthermore, this method did not incorporate an analysis of component degradation or impurities, which is essential for comprehensively evaluating product quality and shelf-life. The document noted that, per a quality agreement, Finecure Pharmaceuticals Limited holds the responsibility for maintaining stability samples and conducting appropriate stability testing. The FDA's issuance of a Form 483 signifies that the agency's representative observed conditions that may represent violations of regulatory requirements. The company is expected to address this observation by implementing comprehensive corrective actions, which can be discussed with the FDA or submitted in writing, to ensure the quality and integrity of its pharmaceutical products.